BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2850053 · Received November 26, 2012

    Report

    Report Number
    3006556115-2012-00533
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT DURING IMPLANT SURGERY, THE PATIENT'S ENLARGED EMISSARY VEIN WAS CUT AND THE PATIENT BLED PROFUSELY. THE SURGEON STOPPED THE BLEEDING WITH BONE WAX. THE PATIENT IS BEING MONITORED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MCM ADVANCED BIONICS, LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention