BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3163559 · Received June 11, 2013

    Report

    Report Number
    9616091-2013-00983
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE RECLINER BRACKET THAT ATTACHES THE SEAT TO THE FRAME AND THE UPPER BOLTS SNAPPED IN HALF ON THE LEFT HND SIDE OF THE ASSEMBLY. TE ASSEMBLY IS ONLY AVAILABLE AS A KIT SO HAD TO PART OUT AS A KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264504 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other