BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 1911755 · Received November 22, 2010

    Report

    Report Number
    3006556115-2010-00571
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PT IS CURRENTLY DOING WELL AND HAS CONTINUED THE USE OF HIS DEVICE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED SWELLING AND THICKENING OF THE SKIN OVER THE IMPLANT SITE. THE PT WAS REPORTEDLY TREATED WITH ANTIBIOTICS (TYPE UNK). THE PT WAS SEEN BY A PHYSICIAN ON (B)(6) 2010 AND NO OBVIOUS INFECTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention