BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4093677 · Received September 16, 2014

    Report

    Report Number
    1531186-2014-04151
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT THE SEAT ON THEIR 9781 I-FIT SHOWER CHAIR CRACKED. USER TRIED TO REPAIR IT WITH SILICONE BUT IT DID NOT STICK AND THE CRACKED PINCHES WHEN HE SITS ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573374 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other