BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2880399 · Received December 19, 2012

    Report

    Report Number
    1531186-2012-01804
    Date Received
    December 19, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 18, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE 6895 SHOWER CHAIR BACK OF THE ARM PIVOT WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other