FDA Adverse Event
Malfunction
Summary report: N
CYTYC SURGICAL PRODUCTS
MDR report key: 1641780
·
Received March 8, 2010
Report
- Report Number
- 1641780
- Event Type
- Malfunction
- Date Received
- March 8, 2010
- Date of Event
- February 5, 2010
- Report Date
- March 8, 2010
- Manufacturer
- CYTYC SURGICAL PRODUCTS
- Product Code
- MNB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
FOLLOWING DEVICE FAILURE, DEVICE WAS TAGGED AND REMOVED FROM AREA, AND SENT TO THE RISK MANAGEMENT DEPARTMENT. THE DEVICE NEVER TOUCHED THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYTYC SURGICAL PRODUCTS | NOVASURE | MNB | CYTYC SURGICAL PRODUCTS | NS2000 | 09H25RA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |