BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2041939 · Received March 29, 2011

    Report

    Report Number
    1525712-2011-00142
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CHIEN TI ENTERPRISE CO. LTD
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY REPORTED. USER WAS TRAVERSING A RAMP WHEN THE INCIDENT HAD OCCURRED. IT'S UNK IF THE RAMP TRAVERSED IS BUILT TO ADA STANDARDS. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR A USER ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MALFUNCTION IS NOT CONFIRMED. CONSUMER ALLEGES, THEY ARE GOING FOR X-RAYS.

    Description of Event or Problem · 1

    THE CONSUMER WAS GOING UP A RAMP WHEN THE SCOOTER ALLEGEDLY WENT BACKWARDS AND LANDED ON TOP OF HER. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI CHIEN TI ENTERPRISE CO. LTD LEO

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR