MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-18 for PLAC manufactured by Diadexus, Llc.
[5543922]
Results from the test vary greatly from lab to lab making it hard for my doctor to tell if i am at risk or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040842 |
| MDR Report Key | 4540913 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-02-18 |
| Date Added to Maude | 2015-02-25 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAC |
| Generic Name | PLAC |
| Product Code | NOE |
| Date Received | 2015-02-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIADEXUS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-18 |