BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY LOCKING TWICE AS TOUGH CUFFS, ANKLE

    MDR report key: 2472334 · Received February 22, 2012

    Report

    Report Number
    2020362-2012-00096
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Report Date
    January 25, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THE LOCKS ON THE ANKLE CUFF DO NOT CLOSE WITH OR WITHOUT THE STRAP INSERTED IN THE LOCK. THE WEBBING AND LOCKS APPEAR TO BE IN GOOD CONDITION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BUCKLE WILL NOT CLICK SHUT. THIS WAS DETECTED THE FIRST TIME IT WAS PUT IN USE. THE STAFF CONTINUED TO USE THE RESTRAINTS. THEY WOULD LOCK THE BUCKLE BY USING THE KEY. THE HOSP HAS LAUNDERED THE PRODUCTS ONCE USING A LAUNDRY BAG AND FOLLOWING OUR INSTRUCTIONS. THE HOSP DOES NOT USE AN OUTSIDE LAUNDRY SERVICE. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY LOCKING TWICE AS TOUGH CUFFS, ANKLE FMQ J. T. POSEY CO. 2799 2006-11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA