BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5076004

    MDR report key: 7365280 · Received March 22, 2018

    Report

    Report Number
    MW5076004
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 21, 2018
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I TOOK A COLOGUARD TEST FOR DETECTING COLON CANCER. POSITIVE RESULT WAS GIVEN TO ME BY PRIMARY CARE PHYSICIAN ON (B)(6) 2018. WENT THROUGH ANGUISH OVER HAVING CANCER AND REPEATED ATTEMPTS TO SCHEDULE A COLONOSCOPY WITH A GASTROENTEROLOGIST. DIFFICULT PROCEDURE FOR ME DUE TO OTHER HEALTH ISSUES SUCH AS HIGH BLOOD PRESSURE AND HEART PALPITATIONS. AFTER THE PROCEDURE ON (B)(6), GASTROENTEROLOGIST TOLD ME IT WAS A FALSE POSITIVE AND I HAD NO CANCER. HE ALSO STATED, "I HAVE SEEN WAY MORE FALSE POSITIVES THAN ACTUAL POSITIVES WITH COLOGUARD."

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other