BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3150134 · Received May 30, 2013

    Report

    Report Number
    3006556115-2013-00227
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY DEVELOPED A SEROMA AROUND THE IMPLANT SITE TWO MONTHS AFTER IMPLANT SURGERY. THE PATIENT WAS TREATED CONSERVATIVELY WITH IV ANTIBIOTICS (TYPE UNKNOWN), BUT THE SEROMA REDEVELOPED. THE PATIENT'S DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237830 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention