FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
MDR report key: 2802458
·
Received October 18, 2012
Report
- Report Number
- 2024601-2012-01108
- Event Type
- Malfunction
- Date Received
- October 18, 2012
- Date of Event
- July 31, 2012
- Report Date
- September 21, 2012
- Manufacturer
- ALLERGAN
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. HEALTH PROFESSIONAL HAS DECLINED TO PROVIDE ADD¿L INFO.
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED: ¿PT HAD BAND EXPLANTED AND REPLACED WITH A NEW BAND. (COMPLICATION OF DEVICE).¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) | LTI | ALLERGAN | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |