BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOGUARD HOME COLON CANCER SCREENING KIT

    MDR report key: 24507204 · Received March 4, 2026

    Report

    Report Number
    MW5184684
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    February 26, 2026
    Report Date
    February 28, 2026
    Manufacturer
    EXACT SCIENCES CORPORATION
    Product Code
    PHP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM A SENIOR PATIENT WHO IS MORBIDLY OBESE WITH LIMITED MOBILITY AND CHRONIC PAIN. I ATTEMPTED TO USE AN AT-HOME STOOL COLLECTION SCREENING KIT (COLOGUARD). DURING THE COLLECTION PROCESS, THE INSTRUCTIONS REQUIRED POSITIONING OVER THE TOILET IN A WAY THAT WAS PHYSICALLY DIFFICULT AND UNSAFE FOR ME. WHILE ATTEMPTING TO COLLECT THE SAMPLE, I EXPERIENCED PHYSICAL INJURY AND SIGNIFICANT PAIN RELATED TO THE REQUIRED POSITIONING AND BALANCE. THE COLLECTION SETUP DID NOT APPEAR TO CONSIDER PEOPLE SUCH AS MYSELF. I FELT AT RISK OF FALLING WHILE TRYING TO COMPLETE THE TEST. I HAD TO STOP THE PROCESS AND WAS LEFT WITH ONGOING PAIN FROM A CUT AND SCRAPE ON MY VULVA AREA, AN BIO HAZARD MESS AND SELF HUMILIATION. I AM CONCERNED THAT OTHER PATIENTS -- ESPECIALLY OLDER ADULTS OR DISABLED PATIENTS -- COULD BE INJURED ATTEMPTING TO USE THIS KIT AT HOME WITHOUT ASSISTANCE OR ADAPTIVE EQUIPMENT. I AM NOT REPORTING A PROBLEM WITH LABORATORY TESTING ACCURACY. I AM REPORTING A SAFETY CONCERN WITH THE PHYSICAL COLLECTION METHOD AND INSTRUCTIONS FOR PATIENTS WITH MOBILITY LIMITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575818 COLOGUARD HOME COLON CANCER SCREENING KIT SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other