BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3140921 · Received June 3, 2013

    Report

    Report Number
    9616091-2013-00935
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE WELD ON THE BOTTOM OF THE BACK BARS OF THE CHAIR HAS BROKEN LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244340 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 40 Other