BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3725542 · Received April 3, 2014

    Report

    Report Number
    9616091-2014-00589
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 5, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHOWER CHAIR SEAT BACK WAS DAMAGED. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202258 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9872

    Patients

    Seq Age Sex Outcome Treatment
    1 Other