D
Patient 1
HEALTHCARE PROFESSIONAL REPORTED PT PRESENTED ABDOMINAL PAIN. LAP-BAND FOUND TO HAVE ERODED THROUGH THE PT'S STOMACH AND WAS REMOVED.
MAUDE MDR 4589072
- MDR report key
- 4589072
- Report number
- 3006722112-2015-00065
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-08-05
- Date received
- 2015-03-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LABOEUF
- Address
- 1120 S CAPITAL OF TX HWY BLDG 1, STE 300 AUSTIN TX 78746 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-09 | 0 | 1. R |
Event Narratives#
N
Patient 1
(B)(4). TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE CATALOG NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. NO ANALYSIS OR TESTING HAS BEEN DONE. EROSION AND ABDOMINAL PAIN ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, PT DATA OR FURTHER EVENT DETAILS.