BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2760592 · Received September 26, 2012

    Report

    Report Number
    1531186-2012-01015
    Date Received
    September 26, 2012
    Report Date
    September 25, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THE LEGS OF THE 9781 I FIT SHOWER CHAIR ARE ALLEGEDLY UNEVEN. CONSUMER STATED THAT WHEN SHE SITS ON THE PRODUCT THE LEGS ARE UNEVEN, SHE ALLEGES THAT SHE HAS FALLEN DUE TO THIS ISSUE. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Other