MAUDE Adverse Event Report: EXACT SCIENCES CORPORATION COLOGUARD ; SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

Cologuard test is unreliable.Exact sciences "cologuard test is an inferior product that leads to very high false positive results.They do not provide any data to the pt or provider, only negative or positive, which is no help at all.Pts are entitled to all info about any medical test or procedure, but the response from exact sciences is that the fda doesn't require them to.Dr (b)(6) at (b)(6) health doesn't recommend cologuard because evidence doesn't back it up.I have found numerous other sources since receiving a "positive" result (with nothing to back it up) that most surgeons and gastroenterologists consider cologuard to be "garbage." how can it possibly be that this product is fda approved? fda safety report id# (b)(4).

• Brand Name: COLOGUARD
• Type of Device: SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION
• Manufacturer (Section D): EXACT SCIENCES CORPORATION
• MDR Report Key: 9750420
• MDR Text Key: 181371723
• Report Number: MW5093239
• Device Sequence Number: 1
• Product Code: PHP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR