BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2993558 · Received March 7, 2013

    Report

    Report Number
    1531186-2013-00945
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE 9781 I-FIT SHOWER CHAIR SEAT WAS CRACKED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97758 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other