BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3123262 · Received May 21, 2013

    Report

    Report Number
    1525712-2013-04035
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    February 11, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE IS (B)(4) 2013.

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE FOOTPLATE WAS CRACKED. THIS ISSUE COLD PREVENT THE USER FROM HAVING ADEQUATE FOOT SUPPORT TO PREVENT THE USER FROM SLIDING OUT OF THE CHAIR OR SUSTAINING ANY OTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224525 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other