BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY TWICE-AS-TOUGH WRIST CUFF, QUICK RELEASE CUFF

    MDR report key: 3040575 · Received March 12, 2013

    Report

    Report Number
    2020362-2013-00110
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - EVAL OF THE RETURNED UNIT CONFIRMED DAMAGE TO THE FEMALE SIDE OF THE QUICK RELEASE BUCKLE. THE BUCKLE IS CRACKED BUT MALE SIDE WILL CLICK INTO FEMALE SIDE. CONNECTING STRAP BUCKLE CLOSES WITH OR WITHOUT STRAP FED THROUGH AND LOCKS SECURELY. CONNECTING STRAP BUCKLE UNLOCKS AS IT SHOULD. NOTE: INSTRUCTIONS FOR USE STATE: BEFORE EACH USE, CHECK CUFFS AND STRAPS FOR CRACKS, TEARS, AND/OR EXCESSIVE WEAR OR STRETCH; CRACKED OR BROKEN BUCKLES OR LOCKS; AND/OR THAT HOOK AND LOOP ADHERES SECURELY, AS THESE MAY ALLOW PATIENT TO REMOVE CUFF. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AFTER THE RESTRAINT HAD BEEN LAUNDERED, THEY NOTICED THERE WAS DAMAGE TO THE FEMALE SIDE OF THE QUICK RELEASE BUCKLE. CUSTOMER CONFIRMS THE RECOMMENDED LAUNDERING INSTRUCTIONS HAVE BEEN FOLLOWED. THIS WAS DISCOVERED DURING SET UP AND THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104324 POSEY TWICE-AS-TOUGH WRIST CUFF, QUICK RELEASE CUFF FMQ J. T. POSEY CO. 279Q 120710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA