FDA Adverse Event
Injury
Summary report: N
MDA
MDR report key: 499422
·
Received December 4, 2003
Report
- Report Number
- 1039284-2003-00012
- Event Type
- Injury
- Date Received
- December 4, 2003
- Date of Event
- October 29, 2003
- Report Date
- December 2, 2003
- Manufacturer
- BIOMERIEUX, INC.
- Product Code
- GKP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TECHNOLOGIST WAS PERFORMING WEEKLY MAINTENANCE ON THE MDA INSTRUMENT WHEN PROBE MOVED AND STABBED THE TECHNOLOGIST. THE TECHNOLOGIST WAS CLEANING THE PROBE WITH AN ALCOHOL WIPE. THE TECHNOLOGIST SUFFERED A PUNCTURE WOUND AND WAS GIVEN AZT PROPHYLACTICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MDA | MULTIPURPOSE IN VITRO COAGULATION INSTRUMENT | GKP | BIOMERIEUX, INC. | MD011 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |