BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM

    MDR report key: 526937 · Received May 25, 2004

    Report

    Report Number
    526937
    Event Type
    Malfunction
    Date Received
    May 25, 2004
    Date of Event
    May 21, 2004
    Report Date
    May 21, 2004
    Manufacturer
    MW MOONEY & CO. INC.
    Product Code
    FNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE WAS REMOVING RINGS FROM PATIENT UTILIZING GEM RING CUTTING SYSTEM INCLUDING FINGER GUARD. DURING CUTTING OF SECOND RING, NURSE NOTED SMALL AMOUNT OF BLOOD UNDER FINGER GUARD. FINGER GUARD THEN NOTED TO BE CUT THROUGH. ABRASION/SMALL LACERATION NOTED PALM SURFACE OF LEFT RING FINGER. FAILURE OF SHIELDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM BATTERY OPERATED RING CUTTER FNS MW MOONEY & CO. INC. 884 C CARBIDE DISK *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other