BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2951136 · Received February 8, 2013

    Report

    Report Number
    1525712-2013-00985
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 8, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE M51 POWER WHEELCHAIR TIPPED FORWARD DURING THE TRANSITION IN AND OUT OF THE LOANER UNIT. ADDITIONALLY SHE REPORTED THAT ALLEGEDLY SHE WAS GETTING BRUISES FROM THE CHAIR, BUT WAS UNABLE TO EXPLAIN HOW AND WHAT PART OF THE UNIT COULD HAVE DONE IT. NO MEDICAL ATTENTION WAS SOUGHT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53504 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M51

    Patients

    Seq Age Sex Outcome Treatment
    1 55 Other