BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1349697 · Received March 20, 2009

    Report

    Report Number
    3006556115-2009-00155
    Event Type
    Injury
    Date Received
    March 20, 2009
    Date of Event
    March 17, 2009
    Report Date
    March 17, 2009
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED AN INFECTION IN HIS IMPLANTED EAR. FURTHER, THE PT WAS HOSPITALIZED WITH MENINGITIS. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO 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 CORPORATION AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R