BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3252419 · Received July 29, 2013

    Report

    Report Number
    1525712-2013-06253
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 11, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE END USER WROTE A LETTER TO ADVISE INVACARE THAT HER HUSBAND WAS USING THE WHEELCHAIR WITHOUT THE LEGRESTS ATTACHED AND A RAW, SHARP EDGE CUT HIS CALF VERY DEEPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353162 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention