BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE PATIENT USE GAIT BELT

    MDR report key: 14112341 · Received April 14, 2022

    Report

    Report Number
    2182318-2022-00029
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Report Date
    May 18, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    IKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION BUT HAS NOT BEEN RECEIVED IN BY THE MANUFACTURER. THEREFORE THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. 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. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).

    Additional Manufacturer Narrative · 0

    H3: 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 NUMBER: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA EMAIL THERE WAS A PHYSICAL THERAPIST WHO HAS SLIPPAGE WHEN USING THE BELT. WILL BE RETURNING FOR INSPECTION. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Description of Event or Problem · 0

    SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639287 SINGLE PATIENT USE GAIT BELT AID, TRANSFER IKX TIDI PRODUCTS 6556L 1355T306

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown