BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4041049 · Received August 27, 2014

    Report

    Report Number
    3008262382-2014-00789
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER CALLED BACK TO ADVISE THAT THE LAST TIME THAT THE ARM BROKE NOW THE METAL IS SHOWING AND LEAVING MARKS ON HER ARM. CONSUMER STATES THE ARM IS BARELY HANGING ON AND SHE HAS THE METAL PART TAPED TO PREVENT ANY CUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520733 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other