BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 2850055 · Received November 26, 2012

    Report

    Report Number
    3006556115-2012-00531
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT HAD A LUMP AT THE IMPLANT SITE AND WAS EXPERIENCING PAIN AND SWELLING. THE PATIENT WAS REPORTEDLY PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN) AND CORTICOSTEROIDS (TYPE UNKNOWN) FOR 3 WEEKS AND INSTRUCTED TO NOT WEAR HER HEADPIECE. THE SWELLING HAS REDUCED AND THERE IS NO EVIDENCE OF INFECTION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING FURTHER INFORMATION. ONCE MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100H-12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention