FDA Adverse Event
Malfunction
Summary report: N
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
MDR report key: 1193494
·
Received October 8, 2008
Report
- Report Number
- 3005992282-2008-00180
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 17, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A LAP ADJUSTABLE BAND PROCEDURE, AS STANDARD PROTOCOL, THE DEVICE WAS LEAK TESTED BEFORE USE. IT FAILED THE LEAK TEST. UNDER PRESSURE, AIR BUBBLES WERE OBSERVED ESCAPING FROM THE DEVICE. NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA | LTI | OBTECH MEDICAL SARL | NA | 20052463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |