FDA Adverse Event
Injury
Summary report: N
BEI MEDICAL SYSTEMS CO
MDR report key: 425681
·
Received October 30, 2002
Report
- Report Number
- MW1026607
- Event Type
- Injury
- Date Received
- October 30, 2002
- Date of Event
- October 18, 2002
- Report Date
- October 28, 2002
- Manufacturer
- BEI MEDICAL SYSTEMS CO.
- Product Code
- MND
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A SECTION OF THE PT'S BOWEL RECEIVED THERMAL DAMAGE SUBSEQUENT TO ENDROMETRIAL ABLATION SURGERY. THIS WAS NOT DISCOVERED UNTIL SURGICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEI MEDICAL SYSTEMS CO | HYDRO THERMABLATOR | MND | BEI MEDICAL SYSTEMS CO. | 56000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| R |