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..
[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
| Report Number | MW5080522 |
| MDR Report Key | 7960454 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-17 |
| Date Added to Maude | 2018-10-12 |
| 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 TEST KIT |
| Generic Name | SYSTEM, COLORECTAL NEOPLASIA |
| Product Code | PHP |
| Date Received | 2018-10-11 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACT SCIENCES CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |