BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE

    MDR report key: 15856438 · Received November 23, 2022

    Report

    Report Number
    8022003-2022-00005
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 23, 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 REVIEWED THE DESIGN HISTORY RECORD AND FOUND ALL MEASUREMENTS TO BE WITHIN SPECIFICATION. THE EASE OF DIFFICULTY OF USE CAN BE A SUBJECTIVE MEASURE 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 ATTEMPTED TO PULL OFF THE COVER AFTER IT WAS NOT BUDGING AND ENDED UP CUTTING THEIR HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240088 SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE SCALPEL GES SOUTHMEDIC INC. 73-0210R W88663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other