BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10533118 · Received September 14, 2020

    Report

    Report Number
    6000034-2020-02599
    Event Type
    Injury
    Date Received
    September 14, 2020
    Report Date
    July 9, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    996472 ASKU NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention