BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1032795 · Received April 23, 2008

    Report

    Report Number
    3006556115-2008-00200
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED BLOOD IN THE MIDDLE EAR AND MASTOID AREA. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS (TYPE UNKNOWN). THE PATIENT'S SKIN FLAP IS SWOLLEN AND THE USE OF EXTERNAL EQUIPMENT IS NOW BEING EVALUATED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. WHEN MORE INFORMATION BECOMES AVAILABLE ADVANCED BIONICS WILL SUBMIT A SUPPLEMENTAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention