FDA Adverse Event
Injury
Summary report: N
GRIP SCALPEL HANDLE #4
MDR report key: 298380
·
Received September 27, 2000
Report
- Report Number
- 298380
- Event Type
- Injury
- Date Received
- September 27, 2000
- Date of Event
- September 21, 2000
- Report Date
- September 26, 2000
- Manufacturer
- SURGIPATH MEDICAL INDUSTRIES, INC.
- Product Code
- GDZ
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATHOLOGIST WORKING ON AUTOPSY. SET SCALPEL DOWN. DESIGN OF HANDLE ALLOWS SCALPEL TO STAY IN UPRIGHT POSITION INSTEAD OF LAYING FLAT. THIS LEFT THE SCALPEL BLADE IN AN UPRIGHT POSITION. PATHOLOGIST'S FINGER GRAZED THE BLADE AND SLICED OPEN THE SKIN. MINIMAL MEDICAL ATTENTION NEEDED FOR THE CUT BUT A SIGNIFICANT BLOOD EXPOSURE TO HIV, HEPATITIS FOR PATHOLOGIST BECAUSE OF THE PT'S HISTORY. PT'S BLOOD TESTED FOR HIV, HEPATITIS, ETC. RESULTS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRIP SCALPEL HANDLE #4 | SCALPEL HANDLE | GDZ | SURGIPATH MEDICAL INDUSTRIES, INC. | #4 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other| R |