BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2802362 · Received October 19, 2012

    Report

    Report Number
    3006556115-2012-00470
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT'S DEVICE WAS EXPLANTED. THE PT WAS A NON-USER AND REQUESTED DEVICE EXPLANT. NO DEVICE ISSUE WAS REPORTED. THERE ARE NO PLANS FOR DEVICE REIMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention