BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2151586 · Received June 29, 2011

    Report

    Report Number
    3006556115-2011-00317
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    October 5, 2004
    Report Date
    June 8, 2011
    Manufacturer
    ADVANCED BIONICS. LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO CHRONIC OTITIS MEDIA. 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-5100H-12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention