BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3974776 · Received August 4, 2014

    Report

    Report Number
    9616091-2014-01386
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED SEAT CRACKED ON RIGHT SIDE FRONT TO BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455005 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 78 Other