FDA Adverse Event
Malfunction
Summary report: N
SAGB QUICK CLOSE
MDR report key: 1100144
·
Received August 5, 2008
Report
- Report Number
- 3005992282-2008-00123
- Event Type
- Malfunction
- Date Received
- August 5, 2008
- Report Date
- July 25, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A LAP ADJUSTABLE BAND PROCEDURE, THE PATIENT HAD AN X-RAY FLURAL FILL AND IT WAS NOTED THAT THE BAND WAS TEARING AT ITS TABS. THE DEVICE IS STILL IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGB QUICK CLOSE | LTI | OBTECH MEDICAL SARL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |