BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAN CUFF, ANKLE

    MDR report key: 3868488 · Received May 8, 2014

    Report

    Report Number
    2020362-2014-00179
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED REPORTED ISSUED; THE METAL SWIVEL CONNECTOR DETACHED FROM THE LEATHER STRAP. A VISUAL INSPECTION REVEALED NO BROKEN THREADS, OR FRAYING IN NEITHER THE CUFF, NOR ANY BROKEN THREADS OR FRAYING ON THE WEBBING. THE POST LOCK AND KEY LOCKS WERE PRESENT. UPON INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THE COMPLAINT WAS DUE TO SUBOPTIMAL SWEDGING OF THE ENDS OF THE U-BAR. ALTHOUGH THE CAUSE OF THE SUBOPTIMAL SWEDGING COULD NOT BE CONFIRMED, BASED ON REVIEW OF PRIOR COMPLAINTS, THIS TYPE OF FAILURE IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE METAL PIECE ATTACHED TO THE RESTRAINT THAT THE STRAP IS THREADED THROUGH, DETACHED. THIS OCCURRED WHILE IT WAS IN USE WITH A PATIENT. CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS OCCURRED OR ANY PATIENT INFORMATION. NO PATIENT/PERSONAL INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278199 CLEAN CUFF, ANKLE FMQ J. T. POSEY COMPANY 2215 020911

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK