MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for COLOGUARD manufactured by Unk.
[134189605]
My sister, (b)(6) saw commercials for cologuard on tv and decided it would be much easier than getting a colonoscopy. She talked to her physician, who ordered cologuard for her. Her results were negative for colon cancer. However, after having severe back pain about a year later, she went to the emergency room at the (b)(6) medical center in (b)(6), the end of (b)(6) 2018. An mri or scan showed she had multiple tumors on her colon. Her diagnosis was colon cancer with no treatment available that would put her in remission. She died 12 days later on (b)(6) 2018. I believe cologuard's commercial on tv are very misleading and deceptive stating if you're at average risk for colon cancer why take 2 days off work or drink that horrible liquid for prep, just ask your dr to order cologuard. You can call me, (b)(6), on (b)(6) if you need add'l info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083352 |
| MDR Report Key | 8277562 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-23 |
| Date of Event | 2017-08-01 |
| Date Added to Maude | 2019-01-25 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 NEOPLASIA, AND HEMOGLOBIN DNA METHYLATION DETECTION |
| Product Code | PHP |
| Date Received | 2019-01-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2019-01-24 |