BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3133306 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00907
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    November 27, 2012
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE (11/27/2012). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL (05/22/2013). POTENTIAL FOR FALLING INJURY ASSOCIATED WITH A BROKEN FRAME ON A 9630-1 COMMODE.

    Description of Event or Problem · 1

    THE DEALER REPORTS THAT THE FRAME IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236126 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other