BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP1000 PROCESSING UNIT BULK, GREY

    MDR report key: 12872695 · Received November 24, 2021

    Report

    Report Number
    6000034-2021-03772
    Event Type
    Injury
    Date Received
    November 24, 2021
    Report Date
    January 4, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS OR INITIAL MDR SUBMITTED ON NOVEMBER 25, 2021, WAS FILED INADVERTENTLY. NO SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON JANUARY 25, 2022.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOV 25, 2021.

    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
    1764692 CP1000 PROCESSING UNIT BULK, GREY NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other