PSYCHEMEDICS HAIR TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-13 for PSYCHEMEDICS HAIR TEST manufactured by Psychemedic Corp..

Event Text Entries

[1999415] Urgent atmosphere to secure employment from job offer already working in dept of (b)(6). Sustained traumatic and painful fingernail clipping through hyponychium of all ten fingernails. Experienced sweating, nervousness, apprehension and fingertips turning blue throughout the procedure for pre employment drug screening. Using standard fingernail clippers from the common desk drawer, the sample collector applied the clipping device under the desktop lighted magnifier without any anesthesia nor provision for the subsequent bleeding. Recognizing the distress and my reluctance to proceed with the other hand, the sample collector sternly warned that if i did not do this that i would not get my job. I then continued with submission as the procedure was repeated on the other hand. Noticing the bleeding after the procedure i asked the sample collector were the nail clippers clean and she replied yes while wiping the cutting edges with a cotton swab dampened with alcohol. She gave me a cotton swab and assured me that the bleeding would soon stop. Upon returning to work the following week with still sore fingertips, the company nurse put me on light duty for one day to recuperate. This procedure was later found to be unacceptable and another test was scheduled for leg hair removal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5020598
• MDR Report Key: 2093865
• Date Received: 2011-05-13
• Date of Report: 2011-05-06
• Date of Event: 2002-08-19
• Date Added to Maude: 2011-05-25
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• 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

Device Details

• Brand Name: PSYCHEMEDICS HAIR TEST
• Generic Name: PSYCHEMEDICS HAIR TEST
• Product Code: DJG
• Date Received: 2011-05-13
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PSYCHEMEDIC CORP.
• Manufacturer Address: 125 NAGOG PARK, STE. 200 ACTON MA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2011-05-13