FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
MDR report key: 2161080
·
Received June 17, 2011
Report
- Report Number
- 2024601-2011-00496
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- October 5, 2010
- Report Date
- May 24, 2011
- 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). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED, THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED, THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH A SURGICAL END CUT TO REMOVE THE DEVICE. 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."
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED LAP-BAND PORT EXPLANT DUE TO AN ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM | LTI | ALLERGAN | NA | 620447 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |