BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1930587 · Received December 6, 2010

    Report

    Report Number
    3006556115-2010-00618
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED AN INFECTION AT THE IMPLANT SITE. THE PT WAS TREATED FOR THE INFECTION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFORMATION IS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention