FDA Adverse Event
Injury
Summary report: N
SOUTHMEDIC NON-STERILE DISPOSABLE SCALPEL
MDR report key: 7737077
·
Received July 31, 2018
Report
- Report Number
- 8022032-2018-00002
- Event Type
- Injury
- Date Received
- July 31, 2018
- Report Date
- June 5, 2018
- Manufacturer
- SOUTHMEDIC INC.
- Product Code
- GES
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHAT: CAP IS TIGHT ON 73-0210R. TWO USERS SUFFERED INJURIES (CUT ON THE HAND BELOW THE PINKY FINGER) AS THEY WERE STRUGGLING TO REMOVE THE CAP. PART NUMBER: 73-0210R, LOT NUMBER: NOT PROVIDED CUSTOMER IMPACT: DIFFICULTY IN USE. HOW: DURING USE. WHEN: DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576816 | SOUTHMEDIC NON-STERILE DISPOSABLE SCALPEL | SCALPEL | GES | SOUTHMEDIC INC. | 73-0210R | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |