BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTRAINTS

    MDR report key: 3588921 · Received January 15, 2014

    Report

    Report Number
    MW5033925
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 14, 2014
    Manufacturer
    DEROYAL
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEROYAL RESTRAINTS WERE NOTED BY STAFF PRIOR TO USE ON PATIENT TO HAVE A MOLDY SMELL. LOT # 1161762 WAS FOUND TO HAVE HYPHAE (A FUNGUS) UNDER MICROSCOPIC EXAMINATION. OTHER INVOLVED LOTS THAT WERE NOTED TO HAVE A MOLDY SMELL WERE # 1092898, 1127981, AND 987496.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37942 RESTRAINTS RESTRAINTS FMQ DEROYAL M2017-U 1161762
    37943 RESTRAINTS RESTRAINTS FMQ DEROYAL M2017-U 1127981
    37944 RESTRAINTS RESTRAINTS FMQ DEROYAL M2017-U 987496
    38038 RESTRAINTS RESTRAINTS FMQ DEROYAL M2017-U 1092898

    Patients

    Seq Age Sex Outcome Treatment
    1 Other