FDA Adverse Event
Malfunction
Summary report: N
SAGB QUICK CLOSE
MDR report key: 1130392
·
Received August 20, 2008
Report
- Report Number
- 3005992282-2008-00140
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- December 1, 2007
- Report Date
- July 31, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 8/20/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE GASTRIC BAND WAS IMPLANTED IN 2006. TWO ADJUSTMENT WERE DONE EIGHT MONTHS LATER, ANOTHER ONE OCCURRED IN 2007, AND THE LAST FIVE MONTHS LATER. IN 2007, THE PATIENT OBSERVED A SPONTANEOUS MISADJUSTMENT OF THE BAND. AN X-RAY WAS CONDUCTED AND NO CONTRAST WAS FOUND. AN ADDITIONAL TEST WAS PERFORMED USING LOPAMIDOL, WHICH SHOWED THAT THERE WAS A BAND LEAK. THE BAND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGB QUICK CLOSE | LTI | OBTECH MEDICAL SARL | NA | 09280503V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |