BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2062642 · Received April 8, 2011

    Report

    Report Number
    3006556115-2011-00150
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    September 19, 2010
    Report Date
    March 18, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE THAT THE PATIENT EXPERIENCED AN INFECTION AND WAS ADMITTED TO A HOSPITAL. THE INFECTION HAS REPORTEDLY BEEN RESOLVED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION.

    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 6 YR Other| R