BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3041585 · Received April 8, 2013

    Report

    Report Number
    6000034-2013-00659
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    December 11, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE MANUFACTURER, THE DEVICE WAS NOT ANALYZED DUE TO UNUSUAL SERIAL NUMBER AND MISSING REGISTRATION . THIS REPORT IS FILED (B)(4). MANUFACTURER DID NOT ASSESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, AN AUDIOLOGIST EXPERIENCED AN ALLERGIC REACTION (DATE NOT REPORTED) SUBSEQUENT TO HANDLING A COCHLEAR IMPLANT DEMONSTRATION PACKAGE, WHICH DID NOT CONTAIN FUNCTIONAL PRODUCT. THE AUDIOLOGIST USED AN EPINEPHRINE AUTOINJECTOR TO TREAT THE ALLERGIC REACTION. NO REPORTS OF FURTHER INJURY ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143073 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention