PSYCHEMEDICS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-19 for PSYCHEMEDICS * manufactured by Psychemedics.

Event Text Entries

[368663] Rptr tested positive for cocaine on two subsequent drug tests performed on samples of hair. All employees are routinely tested 90 days before their birthday. They were given a second test and it was also positive. They had a drug test performed on hair from a different company, quest diagnostics, and the results were positive. They claim there are many other employees in dept that are getting positive results for the cocaine analysis, and reports some have been fired and are appealing through the union, while others have signed waivers and taken suspensions and rehabilitation treatment to keep their jobs. Rptr states during the period of first positive test they were in a relationship with a person that admitted cocaine use, and they discussed the possibilities of passive exposure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW4003925
MDR Report Key	597116
Date Received	2005-04-19
Date of Report	2005-02-16
Date Added to Maude	2005-05-02
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	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	PSYCHEMEDICS
Generic Name	RIA COCAINE METABOLITE ASSAY
Product Code	MVO
Date Received	2005-04-19
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	586946
Manufacturer	PSYCHEMEDICS
Manufacturer Address	* * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-04-19