BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403

    MDR report key: 5222678 · Received November 13, 2015

    Report

    Report Number
    2081283-2015-00007
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Report Date
    February 4, 2016
    Manufacturer
    FREEDOM DESIGNS INC
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN (B)(4) STATE: CUSTOM MANUAL WHEELCHAIRS. FRAME, HOLD FOR DETAILED EVALUATION. PRODUCT RECEIVED EXPANDED EVALUATION. THE EXPANDED EVALUATION REPORT STATES: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE TOP END REVEAL ULTRALIGHT WHEELCHAIR OF HAVING A FRACTURED RIGHT BACK ANGLE PLATE. COMPLAINT WAS CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    END USER IS STATING THAT THE FRAME IS BROKEN.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN (B)(4) STATE: CUSTOM MANUAL WHEELCHAIRS. FRAME, HOLD FOR DETAILED EVALUATION. PRODUCT RECEIVED EXPANDED EVALUATION. THE EXPANDED EVALUATION REPORT STATES: UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR THE TOP END REVEAL ULTRALIGHT WHEELCHAIR OF HAVING A FRACTURED RIGHT BACK ANGLE PLATE. END USER IS STATING THAT THE FRAME IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752676 TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403 WHEELCHAIR, MECHANICAL IOR FREEDOM DESIGNS INC RVL

    Patients

    Seq Age Sex Outcome Treatment
    1