BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUTTLE

    MDR report key: 199694 · Received November 30, 1998

    Report

    Report Number
    MW1015078
    Event Type
    Malfunction
    Date Received
    November 30, 1998
    Date of Event
    November 23, 1998
    Report Date
    November 30, 1998
    Manufacturer
    PRIDE HEALTH CARE, INC.
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER WISHES TO REPORT A "MALFUNCTIONING" SCOOTER. RPTR CLAIMS THAT THE DEVICE IS TOO HARD TO CONTROL, BECAUSE IT WILL NOT DRIVE STRAIGHT. THE DEVICE WON'T DRIVE AT FULL SPEED, PER RPTR. RPTR HAS INFORMED THE DISTRIBUTOR, AND THE RPTR CLAIMS THAT THEY "WON'T LISTEN", AND WILL NOT ASSIST THE RPTR IN REPAIRING THE DEVICE. RPTR IS COMPLETELY BED BOUND WITHOUT THE USE OF THE SCOOTER. RPTR ATTEMPTED TO CONTACT MFR, BUT CLAIMS THAT NO ONE ANSWERED THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUTTLE SCOOTER INI PRIDE HEALTH CARE, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR