BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURIA

    MDR report key: 1180202 · Received September 29, 2008

    Report

    Report Number
    3006556115-2008-00492
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT DEVELOPED AN INFECTION DUE TO HER EXTERNAL EQUIPMENT. IN EARLY 2008, THE PT UNDERWENT SURGERY TO CLEAN THE INFECTION. THE PT WAS RECOMMENDED NOT TO WEAR HEADPIECE UNTIL THE AREA IS FULLY HEALED. THE INFLAMMATION HAS DECREASED. THE PT CONTINUES TO BE MONITORED BY THE CENTRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURIA AURIA SOUND PROCESSOR MCM ADVANCED BIONICS LLC CI-5230-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention