BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY

    MDR report key: 1161273 · Received September 15, 2008

    Report

    Report Number
    3006556115-2008-00456
    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 Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY DEVELOPED AN ULCER ON THE PINNA CAUSED BY THE EXTERNAL EQUIPMENT. THE PT REPORTEDLY USED POLYSPORIN AND MOLESKIN AROUND THE AREA WHILE THE ULCER HEALED. THE PT CONTINUES TO BE MONITORED BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY HARMONY SPEECH PROCESSOR MCM ADVANCED BIONICS LLC CI-5235-300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention