COLOGUARD TEST KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for COLOGUARD TEST KIT manufactured by Exact Sciences Corp..

Event Text Entries

[123685628] Cologuard test stating 92% correct. I was sent a "positive" result by them. It proved to be negative after a colonoscopy and sedation. I would like it documented to add my result to the false positive reports. I believe there is a possibility of over stating their correctness. The doctor and nursing staff had said they had been seeing quite a bit of this false positive from cologuard. This is emotionally, financially and physically stressful.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5080522
MDR Report Key7960454
Date Received2018-10-11
Date of Report2018-10-10
Date of Event2018-09-17
Date Added to Maude2018-10-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCOLOGUARD TEST KIT
Generic NameSYSTEM, COLORECTAL NEOPLASIA
Product CodePHP
Date Received2018-10-11
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEXACT SCIENCES CORP.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-11

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