BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 2475946 · Received February 25, 2012

    Report

    Report Number
    2475946
    Event Type
    Malfunction
    Date Received
    February 25, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 24, 2012
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCTOR CONTROLLING BLEEDING WITH MEDICHOICE CORDLESS CAUTERY. FELT WARMTH NEAR FINGER (SMALL BURN TO FINGER AREA), NOTED GAUZE WITH HOLE BURNING (NO FLAME NOTED). DROPPED GAUZE (THEN STOMPED ON WITH FOOT) AND CAUTERY TO FLOOR. NO BURN TO PATIENT. LOCAL CASE, PATIENT DISCHARGE IMMEDIATELY POST PROCEDURE FROM PACU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE CORDLESS CAUTERY GEI OWENS & MINOR DISTRIBUTION, INC. * 0810-7

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR