BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 374842 · Received January 31, 2002

    Report

    Report Number
    2029203-2001-00117
    Event Type
    Injury
    Date Received
    January 31, 2002
    Date of Event
    June 1, 2001
    Report Date
    January 30, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IN JUNE 200, THE FANTAIL OF THE DEVICE REPORTEDLY BECAME EXPOSED AND THE IMPLANT SITE BECAME INFECTED. FLAP REVISION SURGERY WAS PERFORMED AT THAT TIME AND INFECTION WAS TREATED WITH ANTIBIOTICS. IN 2001, THE IMPLANT SITE BECAME INFECTED AGAIN AND IT WAS DECIDED TO EXPLANT THE DEVICE. IN THE FOLLOWING MONTH, PATIENT WAS REIMPLANTED ON THE CONTRALATERAL SIDE WITH ANOTHER CLARION 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 5 YR Required Intervention