BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURIA HEADPIECE

    MDR report key: 2023834 · Received March 8, 2011

    Report

    Report Number
    3006556115-2011-00085
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING ITCHINESS ABOVE THE IMPLANT SITE WITH THE EXTERNAL EQUIPMENT USE. THE PT WAS PRESCRIBED WITH OINTMENT (TYPE UNK). ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURIA HEADPIECE HEADPIECE MCM ADVANCED BIONICS LLC CI-5304-311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention