SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE
Received Nov 17, 2022 · Event occurred Oct 13, 2022
Report 8022003-2022-00004 · MDR key 15815317
Device
Generic name
Scalpel
Manufacturer
Southmedic Inc.Model number
73-0210RCatalog number
73-0210R
Lot number
W80199
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
Unknown
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
AS PART OF THE INVESTIGATION, SOUTHMEDIC EVALUATED RETAINED PRODUCTION SAMPLES AND FOUND THE SAMPLES TO BE WITHIN SPECIFICATION. THE EASE OF DIFFICULTY OF USE CAN BE A SUBJECTIVE MEASURED DEPENDENT ON THE OPERATOR. SOUTHMEDIC REACHED OUT TO THE DISTRIBUTOR TO SHARE INSTRUCTIONS ON HOW THE COVER CAN BE SAFELY REMOVED.
Description of Event or Problem
USER DESCRIBED SLICING THEIR FINGER DOWN CLOSE THE BONE AT THEIR STUDIO WHILE TRYING TO REMOVE THE CAP. THEY RECEIVED 5 STITCHES IN THEIR INDEX FINGER. THE CAP OF THE DISPOSABLE SCALPEL WAS TIGHT AND THOSE THAT REMAINED AT THE STUDIO WERE EQUALLY AS TIGHT. THE USER FELT THEY WERE DANGEROUS DUE TO HOW TIGHT THE CAP IS AND THE EXTENT OF THEIR INJURY.