BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2132204 · Received June 13, 2011

    Report

    Report Number
    3006556115-2011-00289
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS A SKIN BREAKDOWN AT THE IMPLANT SITE. THE PT REPORTS EXPERIENCING PAIN UNDER THE HEAD PIECE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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