BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL

    MDR report key: 23943694 · Received January 2, 2026

    Report

    Report Number
    MW5181568
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Report Date
    November 10, 2025
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    IWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CIVCO FLOOR MOUNT SYSTEM NEEDED TO BE REPLACED DUE TO AN ISSUE WITH THE PELICAN CASE. 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
    13950 SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL IWJ CIVCO MEDICAL INSTRUMENTS CO., INC. 610-974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other