BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3903257 · Received June 30, 2014

    Report

    Report Number
    9616091-2014-01105
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE 9981 SHOWER CHAIR SAT IN THE WAREHOUSE AND WHEN UNFOLDED IT PIECES OF THE SPACERS CRUMBLED APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380644 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9981

    Patients

    Seq Age Sex Outcome Treatment
    1 Other