BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3800597 · Received May 8, 2014

    Report

    Report Number
    9616091-2014-00830
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    March 31, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT PLASTIC PIECES ON A 9981 SHOWER CHAIR, A SHOWROOM DISPLAY MODEL, BROKE WHERE IT FOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278997 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9981

    Patients

    Seq Age Sex Outcome Treatment
    1 Other