BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE PATIENT GAIT BELT LONG

    MDR report key: 14461807 · Received May 20, 2022

    Report

    Report Number
    2182318-2022-00050
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Report Date
    May 17, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    IKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY PRODUCT WAS RECEIVED UNOPENED AND IN ITS ORIGINAL PACKAGING. EVALUATION OF THE PRODUCT FOUND THAT THE WEBBING EXHIBITED SLIPPAGE OR THE BUCKLE TEETH WAS NOT SECURING THE WEBBING IF THE WEBBING WAS NOT SLIPPED THROUGH THE BUCKLE ALL THE WAY. USING THE IFU APPLICATION, THE WEBBING DID NOT EXHIBIT ANY SLIPPAGE. THERE WERE SEVERAL COMPLAINTS RECEIVED FOR STRAPS SLIPPING WHICH WERE DETERMINED TO BE DUE TO MANUFACTURING ISSUES THAT HAVE BEEN ADDRESSED VIA THE CAPA SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY NONCONFORMITIES AND THE DEVICE PASSED ALL PRODUCT VERIFICATION TESTING AND MET SPECIFICATIONS WHEN SHIPPED INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATE: DURING THE APPLICATION OF THE BELT THE STRAP SHOULD LAY FLAT ACROSS THE BUCKLE. TUCK EXCESS UNDER THE BELT. ALWAYS VERIFY PROPER CLOSURE BEFORE USE. ALWAYS CHECK FOR SKIN INTEGRITY, PROPER CIRCULATION AND RANGE OF MOTION WHEN THE BELT IS IN USE. ENSURE THAT THE BELT IS SECURE AND DOES NOT COMPROMISE THE PATIENT¿S MEDICAL CONDITION AND DOES NOT INTERFERE WITH TUBES, LINES OR OTHER EQUIPMENT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS A PART OF THE MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. MANUFACTURER REFERENCE FILE (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL THEY WANT TO RETURN DUE TO KNOWN GAIT BELT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582046 SINGLE PATIENT GAIT BELT LONG AID, TRANSFER IKX TIDI PRODUCTS 6556L 1335T064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown