BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22818056 · Received August 15, 2025

    Report

    Report Number
    2124215-2025-56111
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 22, 2025
    Report Date
    October 9, 2025
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K)#: (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN BODIES WERE FOUND INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN BODIES WERE FOUND INSIDE THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS HAIR AND DEBRI NOTED PRIMARILY INSIDE THE OUTER BIOHAZARD BAG. THE INNER BIOHAZARD BAG HAD ONE PIECE OF HAIR/DEBRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180506 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 5101 AX1G196559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other