BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE ORTHOSIS, 22"

    MDR report key: 3810060 · Received April 4, 2014

    Report

    Report Number
    3005225477-2014-00004
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    ITQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE STRAP RIPPED OUT FORM THE SEAM WHERE IS WAS SEWN THE PLASTIC CLIP AT THE END OF THE STRAP HIT THE PT IN THE CHIN CAUSING A MINOR ABRASION. THE HOSPITAL HAD TO FILL OUT AN IRIS REPORT FOR THEIR FACILITY WHICH IS STANDARD PROTOCOL FOR THEM WHEN AN INCIDENT LIKE THIS OCCURS. ROOT CAUSE WAS DETERMINED TO THAT TOO MUCH PRESSURE WAS PLACED ON THE BUCKLE WRAP ASSEMBLY, DAMAGING THE STITCHING AND PULLING THE BUCKLE FREE. THERE IS NO ACTION REQUIRED, NO MANUFACTURING ERROR FOUND.

    Description of Event or Problem · 1

    PT PULLED THE STRAP TO TIGHTEN IT AND THE STRAP RIPPED OUT FROM THE SEAM WHERE IT WAS SEWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204735 KNEE ORTHOSIS, 22" JOINT, KNEE, EXTERNAL BRACE ITQ DEROYAL GUATEMALA 27486813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention