BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFLUX

    MDR report key: 4091638 · Received July 17, 2014

    Report

    Report Number
    4091638
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    January 7, 2014
    Report Date
    July 17, 2014
    Manufacturer
    Q-MED AB7
    Product Code
    LNM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    M.D. WAS INJECTING AND LUER LOCK BROKE/EXPLODED.MANUFACTURER RESPONSE FOR DEFLUX INJECTABLE GEL SYRINGE, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417638 DEFLUX AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM Q-MED AB7 * 11889-2

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR