BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD AT-HOME CANCER SCREENING TEST

    MDR report key: 15174617 · Received August 4, 2022

    Report

    Report Number
    MW5111293
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 2, 2022
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COMPANY IS FAILING TO DISCLOSE IN TELEVISION ADVERTISING THAT PRESENCE OF BLOOD COULD RESULT IN A FALSE POSITIVE TEST, AND THAT THE TEST SHOULD NOT BE USED BY PERSONS WHO MAY, FOR A VARIETY OF REASONS, HAVE BLOOD IN THEIR STOOL. THIS DISCLOSURE SHOULD BE ON PAR WITH THE DISCLOSURE THE COMPANY MAKES THAT THE TEST SHOULD NOT BE USED BY PERSONS AT HIGH RISK FOR COLON CANCER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197596 COLOGUARD AT-HOME CANCER SCREENING TEST SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male