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dennis100
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« on: September 08, 2010, 03:38:55 AM »

Event Date 04/09/2002
Event Type Death
Patient Outcome Death;
Event Description
The reporter indicated that the pt was under the care of a sitter and was left unattended while taking a bath. Upon return, the sitter found the pt unresponsive. It was stated that the pt did not have any water in lungs. An autopsy is pending. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=396082
« Last Edit: January 24, 2016, 03:53:02 AM by dennis100 » Logged
dennis100
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« Reply #1 on: September 08, 2010, 03:40:05 AM »

Event Type Death
Patient Outcome Death;
Event Description
It was reported in an article that a patient died due to drowning. No other information regarding the event is available in the article. Attempts for further information from the authors of the article were unsuccessful. Therefore the relationship between the patient's death and vns therapy cannot be determined.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1631947
« Last Edit: January 24, 2016, 03:53:16 AM by dennis100 » Logged
NancyB
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« Reply #2 on: September 10, 2010, 12:08:58 AM »

Dennis, I just wanted you to know that you are INCREDIBLE. I sent your list of 'drownings' to Dr. David Buckles and told him they might want to add that to the warning list. My phone call went well with him yesterday, but today I have to work on a letter he asked me to send him describing exactly what happened to my sister. I wish he could hear all the stories. Each and every person that has suffered from this device deserves to be heard. Cyberonics has no problem publishing success stories. Now IT'S OUR TURN!!!!!
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dennis100
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« Reply #3 on: September 10, 2010, 12:43:25 AM »

You are wasting your time with the FDA.
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Dispatch
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« Reply #4 on: September 10, 2010, 03:14:15 AM »

 Wink

THANKS for all your hard work guys!  KUDDOS!

Cool
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VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
NancyB
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« Reply #5 on: September 10, 2010, 08:30:30 AM »

You know, Dennis, you may very well be right about 'wasting my time.' But, I'd much rather waste my time trying to make a difference in something I truly believe in, then sit back and do nothing at all. My sisters' doctors also thought I was wasting my time demanding they remove the device, because they really believed it was not the device that was causing her problems. But, she is alive today, living at home, and trying to go on with her life and raise her beautiful little girl. When I truly believe that changes need to be made, then I'll 'waste' all the time in the world if I have to, to make those changes happen. Today I sent Dr. Buckles and Lawrence Romanell a copy of the Cyberonics Inc. 10-K report for 6/30/97 which said under 'Device Complications' : 'During the companys' clinical trials, technical complications occurred due to lead wire fractures, battery depletion, and NCP malfunctions. Cyberonics supposedly took care of those problems. So I also sent them the Maude Data Base Reports dating up to this year which show those same problems are still occurring. Cyberonics didn't take care of squat and I let them know it.
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dennis100
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« Reply #6 on: September 08, 2011, 04:54:03 AM »

Event Date 07/21/2008
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated a vns patient had died in a drowning accident. An autopsy was being performed to obtain further information. The vns system was explanted and given to the reporter, who is the patient's daughter. The reporter stated she would return the explanted devices but the devices have not been received to date. All attempts to the reporter's attending neurologist for further information and the autopsy results have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1125599
« Last Edit: January 24, 2016, 03:53:35 AM by dennis100 » Logged
dennis100
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« Reply #7 on: September 09, 2011, 02:49:49 AM »

Event Date 06/17/2008
Event Type Death
Patient Outcome Death;
Event Description
It was reported that a vns patient had decreased. The autopsy report states there was "a witnessed seizure while swimming. " the vns device has been explanted and returned to the manufacturer for analysis. A previous medwatch report (1644487-2006-00319) was submitted for the patient's lead, indicating high impedance was observed in 2006. As the vns system was never replaced, the patient was not receiving vns therapy at the time of death. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1081366
« Last Edit: January 24, 2016, 03:53:47 AM by dennis100 » Logged
dennis100
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« Reply #8 on: September 09, 2011, 02:50:12 AM »

Event Date 01/01/2006
Event Type Death
Patient Outcome Death;
Event Description
Reporter inidcated that vns patient had passed away. It was reported that the patient drowned in her bathtub, presumably from an unattended seizure. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=677001
« Last Edit: January 24, 2016, 03:53:59 AM by dennis100 » Logged
dennis100
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« Reply #9 on: September 09, 2011, 02:50:36 AM »

Event Date 11/07/2004
Event Type Death
Patient Outcome Death;
Event Description
In the process of contacting the patient's physician to notify him that the patient's device may be nearing end of life, it was discovered that the patient had passed away. Cause of death is not known at this time. Review of manufacturing records for both the pulse generator and the biopolar lead revealed no anomalies that would adversely affect device performance. There is no evidence at this time that th ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=596439
« Last Edit: January 24, 2016, 03:54:11 AM by dennis100 » Logged
dennis100
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« Reply #10 on: September 09, 2011, 02:51:16 AM »

Event Date 03/20/2005
Event Type Death
Patient Outcome Death;
Event Description
Vns patient had passed away. It was reported that the pt had a seizure while in the bathtub and drowned. No autopsy was performed. The pt reportedly experienced a >50% reduction in seizures with the vns therapy and was receiving therapy at the time of death. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=592466
« Last Edit: January 24, 2016, 03:54:23 AM by dennis100 » Logged
dennis100
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« Reply #11 on: September 09, 2011, 02:51:51 AM »

Event Date 12/23/2004
Event Type Death
Patient Outcome Death;
Event Description
Further follow-up revealed that the autopsy findings were listed as: 1. Drowning associated with seizure disorder: a. History of severe seizure disorder. B. History that decreased was found inside a bathtub which contained water. C. Pulmonary edema. 2. History that decreased was found inside his residence bathroom where he was taking bath.

Event Description
Reporter indicated that vns pt had passed away in the hosp. The pathologist who performed the pt's autopsy indicated that the pt was found dead in the bathtub. The cause of death is unk. Autopsy results are pending. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Device programming history did not revealed any anomalies that indicated device malfunction. Device diagnostic testing approximately six months prior to the pt's detah was within normal limits, indicating that the device was functioning properly at that time. Battery life analysis performed with available device programming history revealed that the device had an estimate of 2. 91 years left until end of service. This estimation does not take into consideration magnet activation, programming, diagnostics and interrogations events, which also deplete the battery. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=568145
« Last Edit: January 24, 2016, 03:54:40 AM by dennis100 » Logged
dennis100
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« Reply #12 on: September 09, 2011, 02:52:26 AM »

Event Date 03/15/2002
Event Type Death
Patient Outcome Death;
Event Description
Manufacturer periodically compares device tracking information to the social security death index for the purpose of updating device tracking data. Manufacturer became aware of pt death during this process and evaluated available information against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional information regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt drowned in a pond at a golf course. Other significant condition listed on the death certificate was seizure disorder. An autopsy was not performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=540179
« Last Edit: January 24, 2016, 03:54:52 AM by dennis100 » Logged
dennis100
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« Reply #13 on: September 09, 2011, 02:53:03 AM »

Event Date 08/30/2001
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares device tracking information to the social security death index for the purpose of updating device tracing data. Mfr became aware of pt death during this process and evaluated available information against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain additional information regarding pt deaths for summary reporting request, certificate of death, received and reviewed by mfr. Death certificate indicates that the immediate cause of death was 'fresh water drowning" due to "chronic seizure disorder. " the pt drowned in a hot tub. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=540292
« Last Edit: January 24, 2016, 03:55:07 AM by dennis100 » Logged
dennis100
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« Reply #14 on: September 09, 2011, 02:53:34 AM »

Event Date 04/02/2004
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that depression pt had passed away due to apparent suicidal drowning. The pt was reportedly receiving vns therapy at the time of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525921
« Last Edit: January 24, 2016, 03:55:22 AM by dennis100 » Logged
dennis100
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« Reply #15 on: September 09, 2011, 02:54:24 AM »

Event Date 09/20/2002
Event Type Death
Patient Outcome Death;
Event Description
Manufacturer periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Manufacturer became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by manufacturer. Death certificate indicates that the pt passed away in hospital emergency room as a result of drowning in bathtub at home. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510642
« Last Edit: January 24, 2016, 03:55:38 AM by dennis100 » Logged
dennis100
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« Reply #16 on: September 09, 2011, 02:55:02 AM »

Event Date 08/17/2002
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain add'l info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died while in hosp e. R. Cause of death is listed as asphyxia, due to or as a consequence of water immersion (drowning), due to or as a consequence of seizure disorder. The pt apparently had a seizure while in a lake. No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510653
« Last Edit: January 24, 2016, 03:55:51 AM by dennis100 » Logged
dennis100
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« Reply #17 on: September 09, 2011, 02:55:29 AM »

Event Date 10/05/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. Death certificate indicates cause of death as bathtub drowning secondary to chronic seizure disorder. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=506686
« Last Edit: January 24, 2016, 03:56:03 AM by dennis100 » Logged
dennis100
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« Reply #18 on: September 09, 2011, 02:56:02 AM »

Event Date 03/29/2003
Event Type Death
Patient Outcome Death;
Event Description
Mfr periodically compares devies tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evalauted available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died while hosptialized. Immediate cause of death is listed as near drowning. The pt reportedly had an epileptic seizure while in the bath tub and nearly drowned two days prior to date of death. No autopsy was performed. There is no evidence that the ncp system caused or contributed to the requested event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=507050
« Last Edit: January 24, 2016, 03:56:19 AM by dennis100 » Logged
dennis100
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« Reply #19 on: September 09, 2011, 02:57:03 AM »

Event Date 01/29/2003
Event Type Death
Patient Outcome Death;
Event Description
The pt recently passed away due to drowning in the bathtub as a result of having a seizure. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=453620
« Last Edit: January 24, 2016, 03:57:59 AM by dennis100 » Logged
dennis100
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« Reply #20 on: September 09, 2011, 02:57:39 AM »

Event Date 11/10/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. The pt's caregiver was out of the bathroom when the pt apparently seized and drowned in the bathtub. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=431966
« Last Edit: January 24, 2016, 03:58:13 AM by dennis100 » Logged
dennis100
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« Reply #21 on: September 09, 2011, 02:58:17 AM »

Event Date 10/19/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. The patient was reportedly found dead in the bathtub having been left unsupervised and apparently drowned. Medical examiner believes that the patient had a seizure resulting in loss of consciousness which led to the drowning. Autopsy results are pending. The patient had reportedly experienced a >25% reduction in seizures with the ncp system and was receiving vns therapy at the time of death. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=429429
« Last Edit: January 24, 2016, 03:58:24 AM by dennis100 » Logged
dennis100
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« Reply #22 on: September 09, 2011, 02:58:59 AM »

Event Date 08/21/2000
Event Type Death
Patient Outcome Death;
Event Description
In the process of notifying the patient that their device may be nearing end of service, it was discovered that the patient had passed away. The cause of death is unknown at this time. Further follow-up with the patient's last known physician was unsuccessful in obtaining additional information as the physician indicated that he had previously notified the manufacturer of the patient's death and would therefore not provide further information. The manufacturer has no record of previous notification regarding the patient's death and the physician did not indicate how the manufacturer was previously notified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=416674
« Last Edit: January 24, 2016, 03:58:35 AM by dennis100 » Logged
dennis100
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« Reply #23 on: September 09, 2011, 02:59:25 AM »

Event Date 07/26/2002
Event Type Death
Patient Outcome Death;
Event Description
Rptr indicated that vns pt had passed away. The pt's device had not yet been programmed to "on" following the implant surgery. The pt reportedly drowned. Physician indicated that the ncp system was not related to the pt's death. The pt's device was not explanted. Autopsy results are pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=414003
« Last Edit: January 24, 2016, 03:58:50 AM by dennis100 » Logged
dennis100
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« Reply #24 on: September 09, 2011, 03:00:07 AM »

Event Date 01/29/2001
Event Type Death
Patient Outcome Death;
Event Description
During the process of notifying the pt that their device may be nearing end of service, it was discovered that the pt had passed away. The pt had reportedly died from asphyxia due to drowning from seizures. The pt's ncp system was not explanted. There is no evidence at this time that the ncp system caused or contributed to the reported event. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=410659
« Last Edit: January 24, 2016, 03:59:03 AM by dennis100 » Logged
dennis100
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« Reply #25 on: September 09, 2011, 03:01:00 AM »

Event Date 05/01/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. The patient was found in a lake/swamp having drowned while fishing. Further follow-up revealed that the cause of death was drowning secondary to have a seizure. Autopsy is pending. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=397649
« Last Edit: January 24, 2016, 03:59:19 AM by dennis100 » Logged
dennis100
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« Reply #26 on: September 09, 2011, 03:01:41 AM »

Event Date 09/03/1998
Event Type Death
Manufacturer Narrative
Further follow-up revealed that the patient drowned in the bathtub after a seizure. The patient died at home. An autopsy was not performed. The death certificate listed the immediate cause of death as drowning, due to (or as a likely consequence of) seizure disorder. The manner of death was listed as accident.

Event Description
In the process of contacting the patient to inform patient that generator may be nearing end of service, it was discovered that the patient had passed away. The cause of death is unknown at this time. It is unknown whether the ncp system was explanted. Attempts to obtain additional information have been unsuccessful to date. There is no allegation of device deficiency. There is no indication that the vns caused or contributed to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=397655
« Last Edit: January 24, 2016, 03:59:32 AM by dennis100 » Logged
dennis100
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« Reply #27 on: September 09, 2011, 03:02:10 AM »

Event Date 04/01/1999
Event Type Death
Patient Outcome Death;
Event Description
In the process of contacting the pt to inform them that their generator may be nearing end of service, it was discovered that the pt had expired. The cause of death was reported as drowning due to a seizure. Reporter indicated that the pt was benefiting from the vns therapy. It is unk whether the pt's ncp system was explanted. Attempts to obtain additional info have been unsuccessful to date. There is no allegation of device deficiency. There is no indication that the vns therapy caused contributed to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=390592
« Last Edit: January 24, 2016, 03:59:44 AM by dennis100 » Logged
dennis100
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« Reply #28 on: September 09, 2011, 03:02:43 AM »

Model Number 100
Event Type Death
Patient Outcome Death;
Event Description
In the process of contacting the pt to inform them that their generator may be nearing end of service, it was discovered that the pt had expired. The cause and date of death are unk at this time. It is unk whether the pt's ncp system was explanted. Attempts to obtain additional info have been unsuccessful to date. There is no allegation of device deficiency. There is no indication that the vns therapy caused or contributed to the event.

Manufacturer Narrative
Further follow-up revealed that the pt was found dead in the bathtub. It is presumed that the pt had a seizure and drowned in the bathtub. Conclusions: the physician indicated that the pt never had good seizure control with or without vns stimulation, or multiple medications. The ncp system was explanted one year prior to the pt's death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=390693
« Last Edit: January 24, 2016, 03:59:59 AM by dennis100 » Logged
dennis100
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« Reply #29 on: September 09, 2011, 03:03:11 AM »

Event Date 10/18/2001
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that pt was found dead in the bathtub after having a seizure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=360613
« Last Edit: January 24, 2016, 04:00:14 AM by dennis100 » Logged
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