BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 14519844 · Received May 26, 2022

    Report

    Report Number
    3002968685-2022-00049
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    June 1, 2022
    Report Date
    May 26, 2022
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANT DATE WAS CORRECTED FROM (B)(6) 2022.

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE THAT A PATIENT REQUIRED MEDICATION DUE TO INFECTION.

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE THAT THE PATIENT UNDERWENT AN EXPLANT SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709581 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown