BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 14047997 · Received April 7, 2022

    Report

    Report Number
    3002968685-2022-00029
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 7, 2022
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE THAT PATIENT DEVELOPED AN INFECTION. THE PHYSICIAN PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION.

    Description of Event or Problem · 0

    SEE D6A AND H6 FOR UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940480 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown