BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3133349 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00909
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    October 22, 2012
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.

    Description of Event or Problem · 1

    THE DEALER REPORTS THE COMMODE SEAT IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235796 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other