BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL CONNECTED TWICE AS TOUGH CUFFS, ANKLE

    MDR report key: 3181751 · Received June 6, 2013

    Report

    Report Number
    2020362-2013-00250
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    March 13, 2013
    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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE ISSUE THAT THE BUCKLE ON THE ANKLE CUFF CANNOT BE CLOSED AT ALL. BOTH OF THE CONNECTING STRAP BUCKLES CAN BE CLOSED WITH OR WITHOUT THE STRAP BEING FED THROUGH THEM WITH SOME DIFFICULTY BUT CLICKS SHUT SECURELY WHEN CLOSED. NOTE: THIS RESTRAINT IS A CUSTOM MADE ITEM. THIS RESTRAINT HAS TWO BUCKLES; ONE ON THE ANKLE AND ONE ON THE BED STRAP. (B)(4).

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT AFTER WASHING THE RESTRAINT, THE LOCK BECAME IMPOSSIBLE TO CLOSE DURING TESTING AT THE HOSPITAL. THE HOSPITAL WASHES THE PRODUCT IN NETS. THE DISTRIBUTOR DID NOT PROVIDE THE DATE WHEN THIS WAS DISCOVERED. NO PATIENT OR STAFF INCIDENTS OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252174 SPECIAL CONNECTED TWICE AS TOUGH CUFFS, ANKLE FMQ J. T. POSEY CO. S27957 032711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA