FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ACCESS PORT KIT (UNK SIZE)
MDR report key: 2151163
·
Received June 21, 2011
Report
- Report Number
- 2024601-2011-00504
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- September 27, 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
TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THE ACCESS PORT HAD NON-PENETRATING NICKS WITH STRIATIONS DESCRIBED AS SURGICAL TOOL SCRATCH-LIKE. 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 SYSTEM EXPLANT DUE TO AN ALLEGED PORT LEAK. THE DEVICE HAS BEEN REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ACCESS PORT KIT (UNK SIZE) | LTI | ALLERGAN | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |