BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1952031 · Received December 29, 2010

    Report

    Report Number
    3006556115-2010-00674
    Event Type
    Injury
    Date Received
    December 29, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND RECEIVED A MEDICAL TREATMENT. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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