BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOGUARD

    MDR report key: 11462736 · Received March 10, 2021

    Report

    Report Number
    MW5099938
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Report Date
    March 9, 2021
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A POS RESULT FROM COLOGUARD TEST WITH NO EXPLANATION OF WHY THE COMPANY WILL NOT GIVE ANY MORE THAN THAT. IT IS A BIG WASTE OF TIME AND EFFORT TO DO THE TEST FOR NO INFORMATION FOR ME OR THE DR. SOMEBODY JUST MAKES MONEY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346686 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR