BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2973183 · Received February 21, 2013

    Report

    Report Number
    1531186-2013-00686
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE 6891 SHOWER CHAIR SEAT AND RIGHT FOOTREST ASSEMBLY WELD WERE CRACKED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76123 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other