BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4891502 · Received June 25, 2015

    Report

    Report Number
    4891502
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 25, 2015
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DERMATOLOGIC SURGEONS HAVE OBSERVED THAT A CERTAIN LOT OF SOUTHMEDIC #15 SCALPEL BLADES FEELS DULL AND DOESN'T INCISE A PATIENT'S SKIN AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412307 * SCALPEL GES SOUTHMEDIC, INC. * 21451

    Patients

    Seq Age Sex Outcome Treatment
    1 *