FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
MDR report key: 2160176
·
Received May 18, 2011
Report
- Report Number
- 2024601-2011-00360
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- February 16, 2011
- Report Date
- April 19, 2011
- 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
(B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WAS RETURNED; HOWEVER, THE DEVICE ANALYSIS RESULTS ARE PENDING AT THIS TIME. BASED UPON THE IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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 "PORT EXPLANT DUE TO LEAK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM | LTI | ALLERGAN | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |