BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC SAFETY SCALPEL

    MDR report key: 5155656 · Received October 16, 2015

    Report

    Report Number
    5155656
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Report Date
    October 12, 2015
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SOUTHMEDIC SAFETY SCALPEL, FIVE OUT OF TEN NEW UNOPENED SCALPELS IN LOCK POSITION UNABLE TO USE; TECHNICIAN TRIED TO OPEN (UNSUCCESSFULLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687164 SOUTHMEDIC SAFETY SCALPEL BLADE, SCALPEL GES SOUTHMEDIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1