BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM RING CUTTING SYSTEM

    MDR report key: 1275470 · Received December 24, 2008

    Report

    Report Number
    MW5009420
    Event Type
    Malfunction
    Date Received
    December 24, 2008
    Date of Event
    December 20, 2008
    Report Date
    December 24, 2008
    Manufacturer
    M.W. MOONEY & CO, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD RING ON FINGER THAT WAS TIGHT AND WAS TO BE CUT OFF PRIOR TO GOING INTO SURGERY. THE GUARD WAS PLACED ON PATIENT'S FINGER, WATER SOLUBLE GEL ON THE LEFT RING FINGER. KEEPING THE CUTTER LEVEL USING THE EQUIPMENT PROVIDED, CUT THROUGH THE RING. AFTER 1ST PASS, STOPPED NOTICED BLOOD. PATIENT HAD 1/2 INCH LACERATION TO THE RING FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM RING CUTTING SYSTEM NONE MDM M.W. MOONEY & CO, INC. GEM TITANIUM

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other