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 |