BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3133460 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00912
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    December 18, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE (B)(4) 2012. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.

    Description of Event or Problem · 1

    PROVIDER STATES PART OF HANGER THAT ATTACHES TO CHAIR BENT TOGETHER. THEY DID GET THEM OPENED BUT WILL NOT LOCK INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234324 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9JYLT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other