BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 7075020 · Received November 30, 2017

    Report

    Report Number
    MW5073677
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    September 16, 2017
    Report Date
    November 27, 2017
    Manufacturer
    UNK
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED "COLOGUARD AND RESULT WAS "POSITIVE." WENT FOR A COLONOSCOPY. RESULT CAME BACK "PERFECT." DOCTOR SAID IT WAS A 100% FALSE POSITIVE. NATURALLY HAPPY WITH THE RESULTS, HOWEVER, VERY SHOCKED WHEN DOCTOR SAID "COLOGUARD" DOES IN SOME CASES (ABOUT 13% OF THE TIME). PRODUCE "FALSE POSITIVE" AND "FALSE NEGATIVE" GET A "POSITIVE" AND AUTOMATICALLY YOU SO FOR A COLONOSCOPY. GET A "NEGATIVE" AND YOU ARE "HAPPY". IF PERCHANCE IT IS A "FALSE NEGATIVE", NO ONE KNOWS AND THE CANCER JUST GETS WORSE, TOTALLY UNCHECKED. "COLOGUARD" IS AS BAD AS CAN BE. SHOULD BE TAKEN OF THE MARKET. AS A DIAGNOSTIC TOOL IT IS A SCAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852453 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA PHP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR