BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 4142558 · Received October 1, 2014

    Report

    Report Number
    3006556115-2014-00459
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED REDNESS AT THE IMPLANT SITE WITH A SCAB. THE PATIENT WAS TREATED WITH ANTIBIOTICS ORALLY (AUGMENTIN) AS A PRECAUTION FOR SEVEN DAYS. THE PATIENT HAS CONTINUED TO WEAR THE HEADPIECE WITHOUT ANY ISSUES. THE PATIENT CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611461 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention