BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL WITH POLYMER COATED SURGICAL BLADE

    MDR report key: 5093510 · Received September 22, 2015

    Report

    Report Number
    5093510
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 21, 2015
    Manufacturer
    SOUTHMEDIC INC
    Product Code
    GDX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SAFETY COVER DOES NOT ALWAYS SLIDE EASILY OR NOT AT ALL. THIS CAN CAUSE POTENTIAL LACERATION TO THE USER IF THEY CONTINUE TO TRY TO SLIDE THE SAFETY COVER. SO FAR, NO STAFF OR PATIENTS HAVE BEEN HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624338 SAFETY SCALPEL WITH POLYMER COATED SURGICAL BLADE SCALPEL, ONE-PIECE GDX SOUTHMEDIC INC 020915

    Patients

    Seq Age Sex Outcome Treatment
    1