BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 374389 · Received January 29, 2002

    Report

    Report Number
    2029203-2002-00027
    Event Type
    Injury
    Date Received
    January 29, 2002
    Date of Event
    December 7, 2001
    Report Date
    January 29, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATIONS
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN DECEMBER 2001, THE PATIENT WAS SEEN BY THE CENTER FOR SKIN FLAP BREAKDOWN OVER THE IMPLANT SITE. IT WAS NOTED THAT ONE CORNER OF THE DEVICE WAS PROTRUDING. SURGERY WAS PERFORMED TO REPOSITION THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR