BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1821474 · Received August 24, 2010

    Report

    Report Number
    3006556115-2010-00426
    Event Type
    Injury
    Date Received
    August 24, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT HAD A SKIN FLAP THINNING PROCEDURE PERFORMED. THE COMPANY CONTINUES GATHERING ADDITIONAL INFO. WHEN NEW INFO BECOMES AVAILABLE, A SUPPLEMENT REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention