BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 12260586 · Received July 30, 2021

    Report

    Report Number
    MW5102910
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    April 12, 2021
    Report Date
    July 28, 2021
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE ON COLOGUARD TEST. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147907 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR