BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3846000 · Received June 3, 2014

    Report

    Report Number
    9616091-2014-00981
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 17, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE VINYL PADDED SEAT ON A (B)(4) SHOWER CHAIR WAS CRACKED, USER SUSTAINED A SLIGHT PINCH. NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324863 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9872

    Patients

    Seq Age Sex Outcome Treatment
    1 27 Other