FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
MDR report key: 4190095
·
Received September 18, 2014
Report
- Report Number
- 2024601-2014-00532
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- July 25, 2014
- Report Date
- August 26, 2014
- Manufacturer
- ALLERGAN
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS NOT BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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
HEALTHCARE PROFESSIONAL REPORTED "BROKEN TUBING ON PORT SIDE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 577691 | LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) | LTI | ALLERGAN | NA | 1824528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | NONE DOCUMENTED IN MEDICAL FILE. |