FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 1211152
·
Received October 24, 2008
Report
- Report Number
- 3005992282-2008-00199
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- August 5, 2008
- Report Date
- October 20, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A LAP GASTRIC BAND PROCEDURE THAT WAS COMPLETED IN 2008, THE PATIENT PRESENTED AT THE HOSPITAL WITH ABDOMINAL PAIN AND SWELLING. ON APPROX ONE AND A HALF MONTHS LATER, A CT SCAN WAS DONE. THERE WAS INFLAMMATION AROUND TUBING IN THE STOMACH. ON SAME DATE, BAND WAS EXPLANTED. PATIENT DISCHARGED HOME WITH HOME HEALTH CARE FOR WOUND VAC CARE. ON THE FOLLOWING MONTH, PATIENT COMPLAINED OF NAUSEA. ON TWENTY SIX DAYS LATER, PATIENT STILL ON WITH HOME HEALTH CARE VISITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ADJ GASTRIC BAND STR | LTI | OBTECH MEDICAL SARL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |