BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID URETHRAL BULKING SYSTEM

    MDR report key: 12550869 · Received September 29, 2021

    Report

    Report Number
    3002968685-2021-00043
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    August 25, 2021
    Report Date
    November 11, 2021
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEE SECTION H. NUMBER 6 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PATIENT DEVELOPED PAIN AND FEVER FOLLOWING A BULKAMID INJECTION THAT RESULTED IN HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448170 BULKAMID URETHRAL BULKING SYSTEM AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 20F0102AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown