BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERGONOMIC WALKING BELT

    MDR report key: 2841439 · Received October 23, 2012

    Report

    Report Number
    2020362-2012-00609
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 28, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    IKX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REPORTED ISSUE FOR MALE END HAS DAMAGE TO THE TIP WAS NOT CONFIRMED. NONE OF THE MALE SIDE QUICK RELEASE BUCKLES ARE DAMAGED. HOWEVER, EVALUATION REVEALED THAT ONE OF THE FEMALE SIDE QUICK RELEASE BUCKLES IS CHIPPED ON THE SIDE. ALTHOUGH THE MALE SIDE STILL CLICKS INTO THE DAMAGED FEMALE SIDE, BECAUSE OF THE DAMAGE, IT WILL NOT HAVE THE SAME SECURITY. NOTE: POSEY INSTRUCTIONS FOR USE INDICATE: FASTEN ALL BUCKLES TO MINIMIZE DAMAGE DURING WASH AND DRY CYCLES. DURING THE WASHING, PROCESS, METAL BUCKLES COULD BEND AND QUICK-RELEASE BUCKLES COULD CRACK OR BREAK. DO NOT PUT BUCKLES THROUGH EXTRACTORS. ALWAYS ENSURE THAT ALL BUCKLES ARE IN GOOD WORKING ORDER AND ARE NOT CRACKED OR BROKEN BEFORE EACH USE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TOP QUICK RELEASE BUCKLE MALE END HAS DAMAGE TO THE TIP. THE QUICK RELEASE BUCKLE DOES CONNECT, BUT THE CUSTOMER IS CONCERNED ABOUT THE STRENGTH OF THE CONNECTION. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERGONOMIC WALKING BELT IKX J. T. POSEY CO. 6534XL 062311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK