BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2917152 · Received January 15, 2013

    Report

    Report Number
    1531186-2013-00217
    Date Received
    January 15, 2013
    Report Date
    December 18, 2012
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 153186-2013-00217 INDICTING THE MANUFACTURER AS UNKNOWN. THE ACTUAL MANUFACTURER IS (B)(4).

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER WAS USING CHAIR AS NORMAL AND THE WOOD INSIDE OF THE SHOWER CHAIR SEAT SPLIT CAUSING THE SEAT TO BREAK. THE CLIPS OF THE SEAT DID NOT BREAK, JUST THE SEAT ITSELF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23180 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other