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