BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3033948 · Received April 3, 2013

    Report

    Report Number
    3004493922-2013-00713
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. (B)(4).

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE SHOWER COMMODE IS VERY SHAKY. IF THE COMMODE IS UNSTABLE, IT COULD CAUSE THE USER TO FALL OFF WHEN ATTEMPTING TO USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137009 DAILY ACTIVITY ASSIST DEVICES 890.5050 INM KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other