BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1161272 · Received September 15, 2008

    Report

    Report Number
    3006556115-2008-00462
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT REPORTEDLY HAD A SKIN BREAKDOWN. ALLERGY TESTING IS CURRENTLY PLANNED FOR THIS PT. THE PT CONTINUES TO BE MONITORED BY THE CLINIC. THE COMPANY IS IN THE PROCESS OF GATHERING ADDITIONAL INFO. AS SOON AS NEW INFO IS OBTAINED, 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-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention