FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
MDR report key: 1950001
·
Received December 7, 2010
Report
- Report Number
- 2024601-2010-00982
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Date of Event
- October 8, 2010
- Report Date
- November 9, 2010
- 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
TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2010. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." "CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE."
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED THAT THE ACCESS PORT OF A LAP-BAND DEVICE WAS REPLACED BECAUSE THE PORT WAS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) | LTI | ALLERGAN | NA | 1516605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |