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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

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).

• Brand Name: COLOGUARD
• Type of Device: SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION
• Manufacturer (Section D): EXACT SCIENCES CORPORATION
• MDR Report Key: 11462736
• MDR Text Key: 239469986
• Report Number: MW5099938
• Device Sequence Number: 1
• Product Code: PHP
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/15/2022
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR