FDA Adverse Event Malfunction Summary report: N

PHARMCHEK DRUG PATCH

MDR report key: 19429371 · Received May 29, 2024

Report

Report Number
MW5155592
Event Type
Malfunction
Date Received
May 29, 2024
Date of Event
May 24, 2024
Report Date
May 25, 2024
Manufacturer
PHARMCHEM, INC.
Product Code
FMH
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I AM A CLIENT AT A PLACE CALLED (B)(6). I AM ON A DRUG PATCH TO MONITOR DRUG USAGE AS I AM GETTING OVER A PROBLEM I WAS FACING. THE PATCHES ARE PROVIDED BY A PLACE CALLED PHARMCHEK AND SENT TO A LAB CALLED PHARMCHEM. FOR MONTHS NOW THE NUMBERS ON MY PATCH ARE READING THAT I AM POSITIVE FOR DRUGS ALTHOUGH I TAKE MULTIPLE RANDOM URINE DRUG TESTS A MONTH ALONG WITH 1 HAIR FOLLICLE TEST PER MONTH. AFTER SPEAKING WITH A PLETHORA OF OTHER CLIENTS WE HAVE ALL REALIZED WE ARE HAVING THE SAME ISSUE WITH THE PATCHES NOT ONLY HAVE THEY STARTED MAKING ME BREAK OUT WITH THESE PAINFUL RASHES (AS WELL AS TWO OTHER PEOPLE I'VE TALKED TO.) THESE NUMBERS MAY SEND ME TO JAIL WHEN I KNOW I AM NOT DOING ANYTHING WRONG. THERE HAS TO BE SOMETHING GOING ON AT EITHER THE PHARMCHEM LABORATORY OR AT (B)(6) MAKING AT LEAST 10 OF THE CLIENTS HERE DEAL WITH ISSUES OF INCORRECT TEST RESULTS. I DON¿T KNOW WHERE ELSE TO TURN BUT I AM HOPING SOMETHING CAN BE DONE BY YOU ALL SO MULTIPLE PEOPLE THAT ARE DOING THE RIGHT THING DON'T GO TO JAIL FOR THESE FAULTY PATCHES/RESULTS. THE WAY WE ARE TESTED IS BASED ON ONE STANDARD. I CAN'T IMAGINE EVERYBODY METABOLIZES THESE DRUGS THE SAME AND SWEATS THE SAME AMOUNT. THE PEOPLE PUTTING PATCHES ON DON'T SEEM TO KNOW A THING ABOUT HOW THEY WORK OR WHAT THE NUMBERS/AMOUNT MEAN THEY DON'T SEEM TO BE TRAINED ON ANYTHING EXCEPT SLAPPING THEM ON YOUR ARM. PLEASE HELP! I HAVE HAD MULTIPLE DIFFERENT PATCHES COME BACK THE NUMBERS JUST GO UP AND DOWN UP AND DOWN AROUND NOT SIGNIFICANTLY BUT THESE PEOPLE DON'T KNOW ENOUGH ABOUT THE RESULTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
329811 PHARMCHEK DRUG PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

Patients

Seq Age Sex Outcome Treatment
1 Female Other