MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for COLOGUARD manufactured by Exact Sciences Corporation.
[181371723]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093239 |
| MDR Report Key | 9750420 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-02-25 |
| 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 | 3 |
| Brand Name | COLOGUARD |
| Generic Name | SYSTEM, COLORECTAL NEOPLASIA, DNA METHYLATION AND HEMOGLOBIN DETECTION |
| Product Code | PHP |
| Date Received | 2020-02-24 |
| Device Availability | N |
| 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 | 2020-02-24 |