MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for COLOGUARD manufactured by Exact Sciences Corp..
[103414120]
I took a cologuard test for detecting colon cancer. Positive result was given to me by primary care physician on (b)(6) 2018. Went through anguish over having cancer and repeated attempts to schedule a colonoscopy with a gastroenterologist. Difficult procedure for me due to other health issues such as high blood pressure and heart palpitations. After the procedure on (b)(6), gastroenterologist told me it was a false positive and i had no cancer. He also stated, "i have seen way more false positives than actual positives with cologuard. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076004 |
| MDR Report Key | 7365280 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-26 |
| Date Added to Maude | 2018-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | COLOGUARD |
| Product Code | PHP |
| Date Received | 2018-03-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EXACT SCIENCES CORP. |
| Brand Name | COLOGUARD |
| Generic Name | COLOGUARD |
| Product Code | PHP |
| Date Received | 2018-03-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACT SCIENCE CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-22 |