BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND MITTEN, PADDED, COTTON, LOOP/LOCK, OPTTIE

    MDR report key: 3812545 · Received April 17, 2014

    Report

    Report Number
    3005225477-2014-00006
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 17, 2014
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    FMQ
    PMA / PMN Number
    K963469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENTS WERE CUT AND PINCHED BY THE CLASPS STORED INSIDE OF THE MITTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235915 HAND MITTEN, PADDED, COTTON, LOOP/LOCK, OPTTIE RESTRAINT, PROTECTIVE FMQ DEROYAL GUATEMALA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention