BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2243518 · Received August 30, 2011

    Report

    Report Number
    3006556115-2011-00412
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY FEEL AND HIT HER HEAD. SHE WAS UNCONSCIOUS AFTER THE FALL. THE PT WAS REPORTED HEARING A HUMMING NOISE SINCE THE FALL. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. ADDITIONAL DEVICE TESTING HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention