BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2942778 · Received February 4, 2013

    Report

    Report Number
    1531186-2013-00413
    Date Received
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - TWO MDR REPORTS WILL BE SUBMITTED FOR THIS COMPLAINT, BECAUSE OF DIFFERENT EVENT DATES WERE REPORTED, (B)(4).

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE SAME 91-2 SHOWER CHAIR LEGS WERE BROKEN TWICE, ALTHOUGH THE PATIENT MET THE WEIGHT LIMIT RQUIREMENTS. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47159 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 91-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other