FDA Adverse Event
Malfunction
Summary report: N
ALLERGAN
MDR report key: 2061351
·
Received April 13, 2011
Report
- Report Number
- MW5020274
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 7, 2011
- Manufacturer
- ALLERGAN
- Product Code
- LTI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LAP BAND EXPLANTED ON (B)(6) 2011 FOR WEAR AND TEAR. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLERGAN | LABG 10.0CM ADJUSTABLE GASTRIC BANDING SYSTEM | LTI | ALLERGAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |