FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
MDR report key: 1834503
·
Received September 10, 2010
Report
- Report Number
- 2024601-2010-00757
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TAPER II. (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED TO 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 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 INFO WAS PROVIDED. FURTHER FOLLOW-UP WITH THE HEALTH PROFESSIONAL NOTED THE PORT WAS EXPLANTED DUE TO AN ALLEGED LEAK. "NO DIAGNOSTIC TESTING DONE. PROBLEM FIRST OBSERVED WHEN PT CAME IN WITH NO SALINE IN BAND."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) | LTI | ALLERGAN | NA | 1426604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |