BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3033880 · Received April 3, 2013

    Report

    Report Number
    1531186-2013-01389
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER, THE SEAT HAS BEEN CRACKING FOR TWO YEARS. STATES THAT THE SEATING IS SO BAD IT LEANS WHILE USING IT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137330 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other