*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for * manufactured by Psychemedics Corp.

Event Text Entries

[347977] The reporter applied for a job and as part of the criteria had to take a drug test. Reporter visited a physician who shaved a portion of their leg to obtain a hair sample. The sample was sent to psychemedics for analysis. The dr's office called the complainant 4 days later to tell them that they tested positive for cocaine. Pt then went to another clinic where they removed a sample of hair from their head. This sample was sent to another lab where the panel five test was found to be negative for all substances. Reporter stated that they have never used cocaine in their life and should not have tested positive for any drug.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003880
• MDR Report Key: 570614
• Date Received: 2005-02-02
• Date of Report: 2004-12-20
• Date Added to Maude: 2005-02-08
• 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: *
• Generic Name: *
• Product Code: MVO
• Date Received: 2005-02-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 560462
• Manufacturer: PSYCHEMEDICS CORP
• Manufacturer Address: 5830 UPLANDER WAY CULVER CITY CA 902306608 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-02-02