BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOMAT ILLUMENA INJECTOR SYSTEM

    MDR report key: 18501801 · Received January 11, 2024

    Report

    Report Number
    MW5150167
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    May 23, 2021
    Report Date
    January 10, 2024
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY LLC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USE PROCESS DESCRIPTION: (IT COULDN'T BE POWERED ON, AND THE INDICATOR LIGHT DIDN'T LIGHT UP.) EVENT CAUSE ANALYSIS DESCRIPTION: (BATTERY COULDN'T BE CHARGED.) THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726650 ANGIOMAT ILLUMENA INJECTOR SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT LIEBEL-FLARSHEIM COMPANY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown