BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2202355 · Received August 8, 2011

    Report

    Report Number
    3006556115-2011-00390
    Event Type
    Injury
    Date Received
    August 8, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS HAD AN INFECTION AT THE IMPLANT SITE FOR THE PAST 6 MONTHS. THE IMPLANT SITE IS SWOLLEN AND THE PT HAS BEEN TREATED BY THE IMPLANT SURGEON WITH ANTIBIOTICS (TYPE UNK). THE PT'S FAMILY IS REQUESTING DEVICE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention