MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for COLOGUARD manufactured by Exact Sciences Corporation.
[139196245]
Was prescribed a cologuard test by my primary provider as an alternative to a colonoscopy. He reported the results came back as positive. I found out later, a significant number, both positive and negative, are false. Cologuard test is marketed as an alternative to a colonoscopy. Yet a colonoscopy is required to confirm the results. A false positive wreaks havoc with unnecessary stress. But, think what the consequences are for the person who trusts cologuard and gets a false negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084957 |
| MDR Report Key | 8428304 |
| Date Received | 2019-03-15 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-10-01 |
| Date Added to Maude | 2019-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLOGUARD |
| Generic Name | SYSTEM, COLORECTAL NEOPLASTA, DNA METHYLATION AND HEMOGLOBIN DETECTION |
| Product Code | PHP |
| Date Received | 2019-03-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACT SCIENCES CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |