BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2171308 · Received July 15, 2011

    Report

    Report Number
    3006556115-2011-00352
    Event Type
    Injury
    Date Received
    July 15, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED SWELLING AND REDNESS AT THE IMPLANT SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN) AND ANTIHISTAMINE (TYPE UNKNOWN). ADVANCED BIONICS IS CURRENTLY GATHERING MORE INFORMATION AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention