D
Patient 1
PATIENT'S FRIEND REPORTED THAT THE PATIENT HAD A "GASTRIC BANDING" PROCEDURE, THE PATIENT HAD COMPLICATIONS AND WAS PUT ON A VENTILATOR AND THEN DISCARDED AND RECENTLY PASSED AWAY. THE CAUSE OF DEATH IS NOT KNOWN.
MAUDE MDR 4701383
- MDR report key
- 4701383
- Report number
- 3006722112-2015-00134
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-03-19
- Date received
- 2015-04-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LEBOEUF
- Address
- 1120 S. CAPITAL OF TEXAS HWY BUILDING 1, SUITE 300 AUSTIN TX 78748 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-15 | 0 | 1. D |
Event Narratives#
N
Patient 1
(B)(4) . THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. DEATH AND PULMONARY EMBOLISM ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE CAUSE OF DEATH IS UNKNOWN, IT IS ALSO UNKNOWN IF THE DEVICE IS AN ALLERGAN DEVICE. ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBTS IS IN FAVOR OF REPORTING.