FDA Adverse Event
Injury
Summary report: N
ZIMMER, INC
MDR report key: 14274
·
Received March 11, 1994
Report
- Report Number
- 32966-1994-00001
- Event Type
- Injury
- Date Received
- March 11, 1994
- Date of Event
- January 20, 1994
- Report Date
- February 11, 1994
- Manufacturer
- ZIMMER, INC.
- Product Code
- GCY
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UPON REMOVAL OF HEMMOVAC FROM PT, THE TUBING BROKE OFF. THIS REQUIRED THE PT TO BE OPENED UP TO REMOVE THE IRRIGATION TUBING. THIS WAS PERFORMED IN THE PT'S ROOM UNDER LOCAL ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER, INC Implant | CLOSED WOUND SUNCTION DEVICE | GCY | ZIMMER, INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |