BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3103544 · Received May 9, 2013

    Report

    Report Number
    1531186-2013-01988
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CONSUMER WAS USING THE SHOWER CHAIR AND IT CRACKED IN HALF CAUSING THE USER TO FALL IN THE SHOWER. THE CONSUMER RECEIVED SOME BRUISING FROM THE INCIDENT. NO MEDICAL TREATMENT WAS SOUGHT AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203523 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX POPULAR PLASTICS 9780

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Other