BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE

    MDR report key: 15815317 · Received November 17, 2022

    Report

    Report Number
    8022003-2022-00004
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 13, 2022
    Report Date
    November 17, 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

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168895 SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE SCALPEL GES SOUTHMEDIC INC. 73-0210R W80199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O