BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 374760 · Received January 31, 2002

    Report

    Report Number
    2029203-2002-00011
    Event Type
    Injury
    Date Received
    January 31, 2002
    Date of Event
    July 24, 2001
    Report Date
    January 31, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE PATIENT WAS SEEN AT THE IMPLANT CENTER. AT THAT TIME, IT WAS DETERMINED THERE HAD BEEN A BREAKDOWN OF THE FLAP AT THE IMPLANT SITE. REVISION SURGERY TOOK PLACE THE NEXT DAY TO REPOSITION THE DEVICE; DEVICE REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Required Intervention