FDA Adverse Event
Injury
Summary report: N
SWEDISH ADJUSTABLE GASTRIC BAND
MDR report key: 953093
·
Received November 16, 2007
Report
- Report Number
- 3005992282-2007-00004
- Event Type
- Injury
- Date Received
- November 16, 2007
- Date of Event
- August 8, 2007
- Report Date
- October 16, 2007
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- PMA / PMN Number
- P070009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 11/16/2007. 2100-X SIMILAR BALLOON THAN RLZB22.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SAGB WAS EXPLANTED DUE TO GASTRIC EROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWEDISH ADJUSTABLE GASTRIC BAND | LTI | OBTECH MEDICAL SARL | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |