BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP950 MAGNET (I) (STRENGTH 4) - SINGLE PACKED

    MDR report key: 11548296 · Received March 22, 2021

    Report

    Report Number
    6000034-2021-00747
    Event Type
    Injury
    Date Received
    March 22, 2021
    Report Date
    February 26, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 23, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR MAGNET RETENTION, AND WAS TREATED WITH A TOPICAL STEROID (DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444966 CP950 MAGNET (I) (STRENGTH 4) - SINGLE PACKED NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CP950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention