BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID URETHRAL BULKING SYSTEM

    MDR report key: 14757582 · Received June 21, 2022

    Report

    Report Number
    3002968685-2022-00060
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 21, 2022
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    LNM
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN EXPLANT DUE TO CHRONIC URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625011 BULKAMID URETHRAL BULKING SYSTEM AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM AXONICS MODULATION TECHNOLOGIES, INC. 50050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown