BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1014706 · Received February 22, 2008

    Report

    Report Number
    3006556115-2008-00054
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE COMPANY THAT THE PT DEVELOPED AN INFECTION. THE PT HAS OTORRHEA FROM REAR END OF HIS EAR AND THE PT "SEES PUS INCREASING" AROUND THE IMPLANT. SURGERY TO CLEAR OUT INFECTION AND EXPLANT THE PT'S DEVICE WILL BE SCHEDULED. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF COLLECTING ADD'L INFO. WHEN NEW INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention