URINE ANALYSIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-13 for URINE ANALYSIS manufactured by .

Event Text Entries

[2250227] False-positive drug screen. Tested positive for (b)(6) chemical testing. Consequently, lost job and cannot drive. Sales is my profession. Have been unable to drive for over two yrs due to two duis in five yrs. However, qualified for hardship license program. This testing was part of getting into the program. It took them almost five months to notify me of test results. I am now financially exhausted and will have home foreclosed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022637
MDR Report Key2299699
Date Received2011-10-13
Date of Report2011-10-05
Date of Event2011-05-03
Date Added to Maude2011-10-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameURINE ANALYSIS
Product CodeDJG
Date Received2011-10-13
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2011-10-13

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