PLAC

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5040842
MDR Report Key4540913
Date Received2015-02-18
Date of Report2015-02-18
Date Added to Maude2015-02-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePLAC
Generic NamePLAC
Product CodeNOE
Date Received2015-02-18
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerDIADEXUS, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-18

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