FDA Adverse Event
Other
Summary report: N
ERBE
MDR report key: 102945
·
Received July 3, 1997
Report
- Report Number
- MW1011623
- Event Type
- Other
- Date Received
- July 3, 1997
- Date of Event
- June 23, 1997
- Report Date
- June 24, 1997
- Manufacturer
- ERBE USA, INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT SUSTAINED 2 BURNS ON THE ABDOMEN, SUPERIOR TO THE MYOMECTOMY INCISION LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ERBE | CAUTERY DEVICE | GEI | ERBE USA, INC. | B-1014 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |