BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2850051 · Received November 26, 2012

    Report

    Report Number
    3006556115-2012-00537
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED REDNESS, SWELLING AND SLIGHT BLEEDING AT THE HEADPIECE SITE. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND WAS TREATED WITH ORAL ANTIBIOTICS (KEFLEX) AND OTC TOPICAL OINTMENT. THE PATIENT HAS BEEN CLEARED TO USE THE DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention