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 NumberMW5020598
MDR Report Key2093865
Date Received2011-05-13
Date of Report2011-05-06
Date of Event2002-08-19
Date Added to Maude2011-05-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePSYCHEMEDICS HAIR TEST
Generic NamePSYCHEMEDICS HAIR TEST
Product CodeDJG
Date Received2011-05-13
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerPSYCHEMEDIC CORP.
Manufacturer Address125 NAGOG PARK, STE. 200 ACTON MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2011-05-13

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