FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
MDR report key: 1040370
·
Received May 6, 2008
Report
- Report Number
- 2024601-2008-00234
- Event Type
- Malfunction
- Date Received
- May 6, 2008
- Date of Event
- April 8, 2008
- Report Date
- April 8, 2008
- Manufacturer
- COSTA RICA
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
TAPER II. VISUAL EXAMINATION OF THE RETURNED DEVISE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS RESULTS ARE PENDING AT THIS TIME. A SUPPLEMENTAL MEDWATCH WILL BE GENERATED UPON COMPLETION OF THE PRODUCT ANALYSIS. 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
REPORTED BY THE PT'S HUSBAND AS PORT LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) | DEVICE FOR TREATMENT OF MORBID OBESITY | LTI | COSTA RICA | NA | 1492493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |