BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 9838312 · Received March 16, 2020

    Report

    Report Number
    6000034-2020-00727
    Event Type
    Injury
    Date Received
    March 16, 2020
    Report Date
    February 19, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036818
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 16, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE SKIN FLAP WAS REVISION (UNKNOWN REASON AND DATE OF EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297837 CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI612 NA 09321502036818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention