BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOGUARD

    MDR report key: 11568570 · Received March 24, 2021

    Report

    Report Number
    MW5100255
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    March 22, 2021
    Report Date
    March 22, 2021
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COLOGUARD TEST CAME BACK "POSITIVE." NECESSITATED COLONOSCOPY WHICH MEDICARE AND TRICARE PAID. SURGERY DID NOT SHOW ANY TUMORS. APPARENTLY A FALSE POSITIVE IS NOT UNCOMMON WITH THIS PRODUCT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456488 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization