FDA Adverse Event
Injury
Summary report: N
SAGB QUICK CLOSE
MDR report key: 1000978
·
Received February 19, 2008
Report
- Report Number
- 3005992282-2008-00009
- Event Type
- Injury
- Date Received
- February 19, 2008
- Date of Event
- October 24, 2007
- Report Date
- January 29, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A LAP ADJUSTABLE BAND PROCEDURE, THE PATIENT DEVELOPED AN ABCESS UNDER THE INJECTION PORT DUE TO A MICRO GASTRIC PERFORATION. THE PORT WAS REMOVED AND REPLACED. A FEW DAYS LATER, THE PATIENT DEVELOPED PERITONITIS WITH AN ABCESS UNDER THE LEFT AND RIGHT DIAPHRAGM AND UNDER THE LIVER. HE WAS ALSO NOTED TO HAVE GASTRIC EROSION ON A PERITONITE. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF NINE DAYS. THE BAND WAS REMOVED FROM THE PATIENT. THE PATIENT IS RECOVERING PERFECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGB QUICK CLOSE | LTI | LTI | OBTECH MEDICAL SARL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |