FDA Adverse Event
Malfunction
Summary report: N
GEN2 ADJUSTABLE GASTRIC BAND - 11CM, UNLOCKA
MDR report key: 1460633
·
Received May 19, 2009
Report
- Report Number
- 3005992282-2009-00131
- Event Type
- Malfunction
- Date Received
- May 19, 2009
- Date of Event
- February 11, 2009
- Report Date
- April 30, 2009
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 05/19/2009. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER REMOVING THE BAND FROM THE PACKAGING, A PERFORATION WAS OBSERVED ON THE BAND, JUST BEFORE THE USE. ANOTHER DEVICE WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEN2 ADJUSTABLE GASTRIC BAND - 11CM, UNLOCKA | LTI | OBTECH MEDICAL SARL | NA | 20125349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |