FDA Adverse Event
Summary report: N
NOVASURE
MDR report key: 1251783
·
Received November 24, 2008
Report
- Report Number
- 1251783
- Date Received
- November 24, 2008
- Date of Event
- November 14, 2008
- Report Date
- November 24, 2008
- Manufacturer
- CYTYC SURGICAL SERVICES, INC.
- Product Code
- MNB
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DISPOSABLE HANDPIECE WOULD NOT CALIBRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVASURE | ABLATION SYSTEM, ENDOMETRIAL | MNB | CYTYC SURGICAL SERVICES, INC. | * | 08D19HA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |