BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOGUARD

    MDR report key: 22943492 · Received September 2, 2025

    Report

    Report Number
    MW5175516
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 27, 2025
    Report Date
    August 27, 2025
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE COLOGUARD KIT FOR EARLY DETECTION OF POTENTIAL DISEASES. THEY FAILED TO PROVIDE RESULTS ON AN ACCESSIBLE PLATFORM. THEY HAVE POTENTIALLY FAILED TO PROVIDE CRITICAL INFORMATION IN A TIMELY MANOR. FURTHERMORE THEY OVERBILLED MY INSURANCE COMPANY AND ONLY DISCOVERED THAT WHEN I CONTACTED THEM. IT IS A DANGEROUS ON HOW THIS CORPORATION CONDUCTS BUSINESS. IF I FIND OUT THAT I HAVE ANY ILLNESS I WILL HIRE A LEGAL TEAM TO SET THINGS RIGHT. I REQUESTED A REFUND AND WAS DENIED. THEY OFFERED TO GIVE ME THE REEKS BY PHONE. WHAT IF I WAS TERMINALLY ILL, HOW THE HECK WOULD I HANDLE THAT! NONE, THAT'S WHY I NEED THE INFORMATION. PLEASE LET ME KNOW IF I HAVE RECOURSE. SOMEONE NEEDS TO REPAIR THIS PROBLEM OR TAKE AWAY THEIR ABILITY TO CONDUCT BUSINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335544 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Life Threatening ADVIL WHEN NEEDED.