FDA Adverse Event Malfunction Summary report: N

COLOGUARD

MDR report key: 18274550 · Received December 5, 2023

Report

Report Number
MW5148857
Event Type
Malfunction
Date Received
December 5, 2023
Date of Event
December 1, 2023
Report Date
December 1, 2023
Manufacturer
EXACT SCIENCES CORPORATION
Product Code
PHP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HEALTHCARE PROVIDER ORDERED A SCREENING TEST CALLED COLOGUARD WITHOUT DISCUSSING IT WITH ME OR OBTAINING MY PERMISSION. THE COMPANY WHO MAKES COLOGARD, EXACT SCIENCES, HAS CONTACTED ME NO LESS THAN 10 TIMES VIA MAIL, TEXT, AND EMAIL. I HAVE A HISTORY OF EXTREME MEDICAL ABUSE AND TRAUMA WHICH HAS LED TO CRIPPLING ANXIETY AND PANIC ATTACKS. I MADE MY PROVIDER AWARE OF THIS ON MY FIRST VISIT. DUE TO THIS TRAUMA I DO NOT PARTICIPATE IN "HEALTH SCREENINGS". EACH TIME EXACT SCIENCES CONTACTS ME I HAVE A PANIC ATTACK AND IT TAKES ME DAYS TO RECOVER FROM THE SUBSEQUENT ANXIETY. THE FREQUENCY WITH WHICH THEY HAVE HOUNDED ME IS ABSOLUTELY UNACCEPTABLE AND IS CERTAINLY BECAUSE THEY WANT THE MONEY FOR A TEST THAT HAS BEEN MEDICALLY DEBUNKED. THERE IS NO SYSTEM IN PLACE TO CONTACT EXACT SCIENCES TO ASK THEM TO REMOVE YOU FROM THEIR SYSTEM. I WAS FORCED TO CALL THEM TODAY BY PHONE AFTER RECEIVING ANOTHER LETTER. I SPENT 20 MINUTES ARGUING WITH A PERSON ON THE PHONE AND HAD TO PROVIDE MY PROTECTED PERSONAL INFORMATION REPEATEDLY TO BE REMOVED FROM THEIR SYSTEM. THEY GAVE ME NO ASSURANCES THAT THEY WOULD NOT CONTACT ME AGAIN. I DID NOT ACTUALLY SEND A SAMPLE OF MY FECES TO THIS SHADY AND ABUSIVE COMPANY. THE COLOGUARD TEST HAS BEEN REPEATEDLY DEBUNKED AS IT FREQUENTLY PROVIDES A FALSE POSITIVE LEADING TO UNNECESSARY, PAINFUL, DEMEANING AND INVASIVE TESTS. THEY ARE HARASSING ME BECAUSE THEY WANT THE MONEY FOR A TEST I NEVER AUTHORIZED AND HAVE NO PLAN TO COMPLETE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
877007 COLOGUARD SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION PHP EXACT SCIENCES CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 49 YR Female Other BUPROPION.| CONTRACEPTION.| LEVOTHYROXINE.| LORAZEPAM.| MAGNESIUM.| VITAMIN B12.| VITAMIN D.