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: 4817503 · Received June 4, 2015

    Report

    Report Number
    9616091-2015-01484
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    November 11, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CUSTOM MANUAL WHEELCHAIRS. OTHER, HARDWARE LOOSE/STRIPPED/GONE. 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 NOT CONFIRMED FOR THE RIGHT AND LEFT RECLINER ASSEMBLIES OF HAVING LOOSE HARDWARE. IT WAS CONFIRMED THAT THERE WAS MISSING HARDWARE ON BOTH ASSEMBLIES. COMPLAINT OF "CANES ARE COMING LOOSE BECAUSE THE SCREW IS BACKING OUT ON BOTH BACK CANES" WAS NOT CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES THAT THE CANES ARE COMING LOOSE BECAUSE THE SCREW IS BACKING OUT ON BOTH BACK CANES.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CUSTOM MANUAL WHEELCHAIRS. OTHER, HARDWARE LOOSE/STRIPPED/GONE. 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 NOT CONFIRMED FOR THE RIGHT AND LEFT RECLINER ASSEMBLIES OF HAVING LOOSE HARDWARE. IT WAS CONFIRMED THAT THERE WAS MISSING HARDWARE ON BOTH ASSEMBLIES. CALLER STATES THAT THE CANES ARE COMING LOOSE BECAUSE THE SCREW IS BACKING OUT ON BOTH BACK CANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361424 TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403 WHEELCHAIR, MECHANICAL IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other