BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2955873 · Received February 11, 2013

    Report

    Report Number
    1531186-2013-00509
    Date Received
    February 11, 2013
    Report Date
    February 10, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE I-FIT SHOWER CHAIR SEAT CRACKED DURING USE, SHE FELL IN THE BATHTUB, AND SUSTAINED BRUISES. NO MEDICAL ATTENTION WAS SOUGHT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58435 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other