FDA Adverse Event
Injury
Summary report: N
SOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE
MDR report key: 7741942
·
Received August 2, 2018
Report
- Report Number
- 8022032-2018-00003
- Event Type
- Injury
- Date Received
- August 2, 2018
- Date of Event
- April 17, 2018
- Report Date
- June 27, 2018
- Manufacturer
- SOUTHMEDIC INC.
- Product Code
- GES
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SCALPEL COVER/GUARD WAS TOO TIGHT. A DOCTOR CUT THEIR HAND WHILE TRYING TO REMOVE THE COVER/GUARD DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584836 | SOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE | SCALPEL | GES | SOUTHMEDIC INC. | 73-0211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |