FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 1032913
·
Received April 23, 2008
Report
- Report Number
- 3005992282-2008-00063
- Event Type
- Injury
- Date Received
- April 23, 2008
- Report Date
- March 26, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
THE PT REPORT THAT POST OPERATIVELY TO A GASTRIC BAND IMPLANT, HE WAS ADMITTED TO THE HOSPITAL FOR AN INFECTION AT THE PORT SITE INCISION. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND PT WAS DISCHARGED HOME. IT IS NOTED THAT THE INCISION IS OPEN ABOUT ONE INCH AND CURRENTLY THE SITE IS PACKED WITH GAUZE, AND PT IS TAKING CIPRO TWO TIME A DAY. IT WILL BE DETERMINED AT A LATER DATE IF A REVISION SURGERY WILL BE REQUIRED.
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 | Hospitalization| R |