BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 10446816 · Received August 25, 2020

    Report

    Report Number
    6000034-2020-02287
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    August 4, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    PFO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE, AND WAS TREATED WITH ANTIBIOTICS (TYPE, DURATION, AND SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915169 ASKU COCHLEAR¿ OSIA¿ SYSTEM PFO COCHLEAR LTD ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention