FDA Adverse Event
Malfunction
Summary report: N
THERMACHOICE
MDR report key: 1101003
·
Received July 30, 2008
Report
- Report Number
- 1101003
- Event Type
- Malfunction
- Date Received
- July 30, 2008
- Date of Event
- July 11, 2008
- Report Date
- July 30, 2008
- Manufacturer
- GYNECARE WORLDWIDE
- Product Code
- MKN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
THERMACHOICE UTERINE BALLOON FAILED DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMACHOICE | ENDOMETRIAL ABLATION SYSTEM | MKN | GYNECARE WORLDWIDE | H206TC0031 | AEMGO3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |