BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD TEST KIT

    MDR report key: 22019843 · Received May 14, 2025

    Report

    Report Number
    MW5170355
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Report Date
    May 11, 2025
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A KIT BUT IT HAD ZERO LABELS. WHY IS MY TAX DOLLARS GOING TO MEDICAL IDIOTS? DON'T YOU HAVE PEOPLE CHECKING TO MAKE SURE ALL COMPONENTS ARE IN BOXES FOR TESTS? NO LABELS TO RETURN OR LABEL WHO PERFORMED TEST. NO LABELS IN BOX TO LABEL WHO TOOK TEST. NO LABELS TO PUT ON TEST TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749223 COLOGUARD TEST KIT SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other