BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDRON, INC

    MDR report key: 248361 · Received October 27, 1999

    Report

    Report Number
    1523528-1999-00001
    Event Type
    Malfunction
    Date Received
    October 27, 1999
    Date of Event
    September 27, 1999
    Report Date
    October 27, 1999
    Manufacturer
    GENDRON, INC.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAINTENANCE DEPT OF HOSP REPORTED THAT WHEEL ON BARIATRIC WHEELCHAIR WAS MISSING BOLT, WASHER AND DRIVE KEY AND THAT WHEEL WAS PARTIALLY OFF THE AXLE. GENDRON DETERMINED THAT THE WHEELCHAIR WAS A DEMONSTRATION MODEL AND THAT, PRIOR TO BEING SOLD TO THE USER, THE CHAIR'S WHEELS HAD BEEN TAKEN OFF AND PUT BACK ON IN ORDER TO FIT IN THE BACKSEAT OF A CAR. GENDRON'S INVESTIGATION SUGGESTS THAT THE SALES REP FAILED TO APPROPRIATELY REPLACE THE WHEELS, WHICH RESULTED IN A LOOSENING AND EVENTUAL LOSS OF THE COMPONENTS NOTED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDRON, INC POWER WHEELCHAIR ITI GENDRON, INC. 7500-62-26-19 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN