BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2990705 · Received March 5, 2013

    Report

    Report Number
    9616091-2013-00375
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE 69630-4 COMMODE FRONT CORNER OF THE SEAT WAS CRACKED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94310 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other