BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL LIMB HOLDER

    MDR report key: 3820668 · Received May 5, 2014

    Report

    Report Number
    3005225477-2014-00009
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 5, 2014
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    FMQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1000123222-02/25/2014-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESTRAINT HAD MOLD GROWTH FOUND IN THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267925 DEROYAL LIMB HOLDER RESTRAINT, PROTECTIVE FMQ DEROYAL GUATEMALA 351022841

    Patients

    Seq Age Sex Outcome Treatment
    1