BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3910903 · Received July 2, 2014

    Report

    Report Number
    1531186-2014-02338
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATES THE RUBBER TIP ON THE SHOWER CHAIR IS BROKEN AND SHE IS CONCERNED FOR THE SAFETY FOR THE END USER USING THE UNIT IN THE SHOWER. NO INJURIES NOTED. THE PROVIDER DOESN'T HAVE THE DATE CODE FOR THE CHAIR AND STATES THE END USER DIDN'T PURCHASE THE UNIT FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387314 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX POPULAR PLASTICS 9781-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other