FDA Adverse Event
Injury
Summary report: N
ZIMMER INC.
MDR report key: 221514
·
Received April 21, 1999
Report
- Report Number
- 221514
- Event Type
- Injury
- Date Received
- April 21, 1999
- Date of Event
- February 24, 1999
- Report Date
- February 26, 1999
- Manufacturer
- ZIMMER, INC.
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
DERMATOME MALFUNCTIONED CAUSING SMALL LACERATIONS TO LEFT AND RIGHT THIGHS, WHICH REQUIRED SUTURING. UNIT WAS SENT FOR REPAIR. UNIT WAS CALIBRATED PER PROCEDURE AND BEARINGS WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER INC. | DERMATOME | GFD | ZIMMER, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization| R |