MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for COLOGUARD manufactured by Unk.
[93569681]
Used "cologuard and result was "positive. " went for a colonoscopy. Result came back "perfect. " doctor said it was a 100% false positive. Naturally happy with the results, however, very shocked when doctor said "cologuard" does in some cases (about 13% of the time). Produce "false positive" and "false negative" get a "positive" and automatically you so for a colonoscopy. Get a "negative" and you are "happy". If perchance it is a "false negative", no one knows and the cancer just gets worse, totally unchecked. "cologuard" is as bad as can be. Should be taken of the market. As a diagnostic tool it is a scam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073677 |
| MDR Report Key | 7075020 |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-09-16 |
| Date Added to Maude | 2017-12-01 |
| 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 NEOPLASIA |
| Product Code | PHP |
| Date Received | 2017-11-30 |
| 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 | 2017-11-30 |