BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD STOOL DNA TEST

    MDR report key: 5161681 · Received October 12, 2015

    Report

    Report Number
    MW5057181
    Event Type
    Malfunction
    Date Received
    October 12, 2015
    Report Date
    October 12, 2015
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ONE OF MANY WHO HAD A FALSE POSITIVE WITH THE COLOGUARD TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674607 COLOGUARD STOOL DNA TEST STOOL COLORECTAL CANCER PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other