BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOGUARD PLUS

    MDR report key: 25113912 · Received May 7, 2026

    Report

    Report Number
    MW5187873
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 5, 2026
    Manufacturer
    EXACT SCIENCES CORPORATION- DISCOVERY CAMPUS
    Product Code
    PHP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY GRANDMA TOOK THE COLOGUARD PLUS TEST AND RECEIVED A NEGATIVE RESULT. COLOGUARD TOLD HER THAT PATIENTS WITH A NEGATIVE DO NOT NEED A COLONOSCOPY, SO SHE NEVER FOLLOWED WITH HER DOCTOR. IT'S BEEN ABOUT 3 MONTHS AND HER SYMPTOMS GOT WORSE SO SHE RETURNED TO THE DOCTOR ONLY TO BE TOLD BY THE DOCTOR THAT IF SHE WOULD HAVE RETURNED HER CALL, HE WOULD HAVE RECOMMENDED A COLONOSCOPY GIVEN HER OTHER SYMPTOMS AND SHE TOLD HIM THAT COLOGUARD IS THE ONE WHO SAID SHE DID NOT NEED ONE. I ALSO WENT TO THE COLOGUARD WEBSITE TO GET MORE INFORMATION AND FOUND THIS: "PATIENTS WHO RECEIVE A NEGATIVE COLOGUARD PLUS RESULT DO NOT NEED A COLONOSCOPY." NOW MY GRANDMA IS GOING IN FOR A COLONOSCOPY NOW AND WE HAVE TO WAIT IN AGONY FOR THE RESULTS IN HOPE THAT NOTHING IS WRONG. BUT KNOWING 3 MONTHS PASSED THAT COULD CHANGE HER OUTCOME OF BEING SICK WITH CRC. COLOGUARD SHOULD NOT BE TELLING PEOPLE WHAT THEY HAVE TO DO OR NOT HAVE TO DO. THEY SHOULD ONLY RECOMMEND PATIENTS FOLLOWING BACK UP WITH THEIR DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493537 COLOGUARD PLUS SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION- DISCOVERY CAMPUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other