BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFLUX

    MDR report key: 16093939 · Received January 4, 2023

    Report

    Report Number
    16093939
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    November 16, 2022
    Report Date
    November 17, 2022
    Manufacturer
    PALETTE LIFE SCIENCES, INC.
    Product Code
    LNM
    UDI-DI
    00850004725009
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PREPARING FOR A CYSTOSCOPY W/PIC CYSTOGRAM & BILATERAL DELFUX. THE DOCTOR PUSHED ON THE PLUNGER OF THE DEFLUX INJECTABLE GEL AND THE BARREL FLANGE BROKE OFF. THIS HAPPENED TWICE BEFORE BEING ABLE TO CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178257 DEFLUX AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM PALETTE LIFE SCIENCES, INC. GEL 1.0 ML SYRINGE 18659 00850004725009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown