BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 10405908 · Received August 14, 2020

    Report

    Report Number
    6000034-2020-02138
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 27, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502009317
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A SUBCUTANEOUS SEROMA AT THE IMPLANT SITE, AND WAS TREATED WITH ORAL STEROIDS FOR A DURATION OF 7 DAYS, AND A COMBINED ANTIBIOTIC/STEROID TOPICAL OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875250 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (ST) NA 09321502009317

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention