BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP1000 PROCESSING UNIT BULK, GREY

    MDR report key: 12872698 · Received November 24, 2021

    Report

    Report Number
    6000034-2021-03773
    Event Type
    Injury
    Date Received
    November 24, 2021
    Report Date
    January 4, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOV 25, 2021.

    Description of Event or Problem · 0

    THE PREVIOUS OR INITIAL MDR SUBMITTED ON NOVEMBER 25, 2021, WAS FILED INADVERTENTLY. NO SERIOUS INJURY HAS OCCURRED.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A HOLE AT THE BACK OF THE EAR WHICH IS PAINFUL WHEN PRESSURE FROM THE PROCESSOR IS APPLIED. THE IMPLANT REMAINS IN-SITU. FURTHER INFORMATION IS BEING SOUGHT FROM THE CLINIC. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764694 CP1000 PROCESSING UNIT BULK, GREY NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other