BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10584221 · Received September 24, 2020

    Report

    Report Number
    6000034-2020-02712
    Event Type
    Injury
    Date Received
    September 24, 2020
    Report Date
    September 4, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN NECROSIS DUE TO MAGNET RETENTION ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045038 ASKU NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention