FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 371597
·
Received January 14, 2002
Report
- Report Number
- 371597
- Event Type
- Malfunction
- Date Received
- January 14, 2002
- Date of Event
- November 16, 2001
- Report Date
- November 30, 2001
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- FFO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
BOOK WALTER ATTACHMENT BROKE OFF FROM RETACTOR WHILE INSTRUMENT BEING USED. ALL PIECES RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | BOOKWALTER TILTER RATCHET MECHANISM | FFO | CODMAN & SHURTLEFF, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |