MAUDE MDR 2093865

MDR report key
2093865
Report number
MW5020598
Event key
0
Event type
3
Date of event
2002-08-19
Date received
2011-05-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PSYCHEMEDICS HAIR TESTPSYCHEMEDICS HAIR TESTPSYCHEMEDIC CORP.DJGUNK

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-1301. R; 2. S

Event Narratives#

D

Patient 1

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.