FDA Adverse Event
Malfunction
Summary report: N
SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE
MDR report key: 14453279
·
Received May 20, 2022
Report
- Report Number
- 8022003-2022-00001
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- April 20, 2022
- Report Date
- May 18, 2022
- Manufacturer
- SOUTHMEDIC INC.
- Product Code
- GES
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
AN ESTHETICIAN WAS IN THE PROCESS OF REMOVING THE COVER TO THE BLADE AND FOUND IT HARD TO GET OFF AND ENDED UP SLICING HER HAND, RESULTING IN 7 STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1186140 | SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE | SCALPEL | GES | SOUTHMEDIC INC. | 73-0210R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| H |