FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
MDR report key: 1834476
·
Received September 10, 2010
Report
- Report Number
- 2024601-2010-00699
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 26, 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. (B)(4). 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."
Description of Event or Problem · 1
RECEIVED A VOICEMAIL MESSAGE FROM HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. FURTHER FOLLOW-UP WITH THE HEALTH PROFESSIONAL NOTED THE PORT WAS EXPLANTED DUE TO AN ALLEGED LEAK.
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 | 60 YR |