BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1961370 · Received January 7, 2011

    Report

    Report Number
    3006556115-2010-00685
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 17, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED A SKIN FLAP INFECTION AT THE IMPLANT SITE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADD'L INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFO IS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention