BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3191597 · Received June 26, 2013

    Report

    Report Number
    9616091-2013-01077
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER THE H BLOCK WITH SOCKET CUP THAT SUPPORTS THE RIGHT ARM REST FRONT MOUNTING BROKE IN HALF WHERE IT SCREWS INTO THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291596 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other