BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 384875 · Received March 25, 2002

    Report

    Report Number
    2029203-2002-00067
    Event Type
    Injury
    Date Received
    March 25, 2002
    Date of Event
    November 1, 2001
    Report Date
    March 25, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT CENTER RECENTLY PROVIDED THE INFORMAITON THAT THE PATIENT WAS EXPLANTED IN 2001 DUE TO INFECTION UNRELATED TO THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention