BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 23077461 · Received September 17, 2025

    Report

    Report Number
    MW5176204
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 13, 2025
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A CRUCIAL COMPONENT IN THE KIT FOR DETECTING OCCULT BLOOD IS THE PROBE. INSTRUCTIONS ARE TO COAT GROOVES IN PROBE WITH STOOL SAMPLE. GROOVES ARE SO SHALLOW AS TO BE NONEXISTENT AND STOOL WON'T ADHERE. CUSTOMER SERVICE HAS BEEN "OFFSHORED" APPARENTLY TO PHILIPPINES. PHONE REP HAD POOR GRASP OF ENGLISH AND DIDN'T UNDERSTAND PROBLEM. HAD TO INSIST ON BEING TRANSFERRED TO A SUPERVISOR, WHO BASICALLY OFFERED NO REMEDY TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577534 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female