BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10533119 · Received September 14, 2020

    Report

    Report Number
    6000034-2020-02600
    Event Type
    Injury
    Date Received
    September 14, 2020
    Report Date
    July 9, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN ABRASION AT THE MAGNET SITE WHICH WAS TREATED WITH A TOPICAL ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996473 ASKU NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention