BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1927763 · Received December 9, 2010

    Report

    Report Number
    2438477-2010-00019
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    January 24, 2006
    Report Date
    November 10, 2010
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED AN ACCIDENT REPORT FROM AN ATTORNEY'S OFFICE ALLEGING THAT THE CLAIMANT WAS INJURED DUE TO A FALL FROM A 3-WHEELED POWER SCOOTER THAT WAS ORIGINALLY DISTRIBUTED BY DRIVE MEDICAL. IT WAS REPORTED THAT THE CLAIMANT WAS SEATED ON LEFT SIDE OF A BUS IN THE SCOOTER. WHILE THE BUS WAS MAKING A LEFT TURN, THE CLAIMANT ALLEGEDLY LOST BALANCE AND FELL SIDEWAYS TO HER RIGHT AND HEAD FIRST INTO REAR DOOR STEP WELL INJURING LEFT LEG, RIGHT SHOULDER, AND BACK. IT WAS REPORTED THAT ONLY THE RIGHT-REAR OF THE 3-WHEELED SCOOTER WAS STRAPPED WITH THE REAR RESTRAINT. THE LEFT PART OF THE SCOOTER WAS NOT STRAPPED. IN ADDITION, THE CLAIMANT WAS NOT WEARING A SEAT BELT WHILE SITTING ON THE SCOOTER. NO DEFECT AND/OR MALFUNCTION ON THE SCOOTER HAS BEEN REPORTED TO DRIVE MEDICAL. THE ALLEGED SCOOTER HAS NOT BEEN RETURNED FOR EVALUATION UP-TO-DATE. THIS MDR REPORT IS BASED ON THE ATTORNEY'S ACCIDENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL MOTORIZED 3-WHEELED VEHICLE INI WU'S TECH CO., LTD. PHANTOM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention