FDA Adverse Event Injury Summary report: N

PHARMCHEK DRUG SWEAT PATCH

MDR report key: 18450073 · Received January 4, 2024

Report

Report Number
MW5149804
Event Type
Injury
Date Received
January 4, 2024
Date of Event
February 10, 2023
Report Date
December 30, 2023
Manufacturer
PHARMCHEM, INC.
Product Code
FMH
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY FIRST PHARMCHEK DRUG SWEAT PATCH WAS PUT ON ME (B)(6) 2023, I HAVE HAD 10 SWEAT PATCHES, AND 29 URINE SAMPLES SINCE THAT TIME. THESE PATCHES ARE ENVIRONMENTALLY CONTAMINATED (METH POSITIVE). AND WHEN THEY ARE IT MEANS YOUR CHILDREN, OR YOUR FREEDOM. 40% FALSE POSITIVE IS TOO HIGH OF A NUMBER. EVEN PHARMCHECK WEBSITE USE TO HAVE A TRAINING VIDEO STATING THAT THE DRUG PATCH NEEDS TO BE USED WITH A SECONDARY TESTING METHOD (THIS VIDEO IS NO LONGER AVAILABLE TO THE PUBLIC). I WILL BE LISTING ALL OF MY TEST DATES ALONG WITH RESULTS AND IF UA WAS GIVEN AT THAT TIME AND THE RESULTS OF THE UA. THIS WILL SHOW THAT SECONDARY TESTING WHILE WEARING A PATCH SHOULD ALWAYS HAPPEN. EACH OF THE PATCHES WAS TESTED AT THE PHARMCHEK LAB (PATCHES WERE WORN FOR 5 TO 14 DAYS AT A TIME), AND UA WERE TESTED ELSEWHERE. ALL UA ARE OBSERVED UA AND WERE SENT IN FOR LAB TESTED RESULTS. ANYONE THAT IS WEARING A DRUG SWEAT PATCH NEEDS TO HAVE UAS EVERY OTHER DAY, OR AT LEAST 3 TIMES DURING THE DURATION OF THE PATCH BEING WORN. IF DRUG SWEAT PATCH IS COMING BACK AS POSITIVE FOR METH THE UA IS NEGATIVE THAT MEANS YOU GOT CONTAMINATED SOMEWHERE (PUBLIC BATHROOM, HOTEL, SEXUAL PARTNER). MAJORITY OF THESE UA ARE PAID OUT OF POCKET SO THAT I COULD PROVE THAT I WASN¿T USING METH. I ALSO PAID FOR MY OWN PATCH BESIDES THE ONE THAT THE COUNTY WAS PUTTING ON ME. HERE ARE THE DATES AND RESULTS: (B)(6) PATCH 1 POSITIVE -UA (B)(6) POSITIVE (BUT HAD SOME KIND OF AMPHETAMINE BLOCKER UNKNOWN TO THE LAB) UA (B)(6) NEGATIVE, UA (B)(6) NEGATIVE (B)(6) POSITIVE PATCH -NO UA COMPLETED (B)(6) POSITIVE PATCH- UA (B)(6) NEGATIVE (B)(6) NEGATIVE PATCH- UA (B)(6) NEGATIVE (B)(6) NEGATIVE PATCH -7 UA COMPLETED ALL NEGATIVE (B)(6) NEGATIVE PATCH -5 UA COMPLETED ALL NEGATIVE (B)(6) NEGATIVE PATCH -2 UA COMPLETED ALL NEGATIVE (B)(6) NEGATIVE PATCH ¿ 3 UA COMPLETED ALL NEGATIVE (B)(6) POSITIVE PATCH - 7 UA COMPLETED ALL NEGATIVE (THIS PATCH WAS ORIGINALLY ON FOR THE FULL 14 DAYS BUT HAD FALLEN OFF OF MY ARM, MY CPS WORKER PICKED IT UP WHEN SHE WAS AVAILABLE) THE US DEPARTMENT OF JUSTICE USES THIS COMPANY FOR PROBATION, PAROLE, AND CHILD PROTECTION CASE ALL OVER THE US. MY CHILDREN WERE REMOVED FROM MY HOME AND MY COUNTY FILED FOR REMOVAL OF PARENTAL RIGHTS. I AM LUCKILY THAT I HAVE A GREAT SUPPORT SYSTEM, AND THAT I AM ABLE TO TAKE THE EXTRA STEPS TO PROVE MY SOBRIETY. BUT FOR SO MANY THIS COSTS THEM TO MUCH (FAMILY, KIDS, FREEDOM, PRISON TIME). SWEAT PATCH WILL TELL YOU ALL DAY THAT THESE PATCHES ARE NOT ENVIRONMENTALLY CONTAMINATED, THAT THE EXTRA PLASTIC OVERLAY PREVENTS CONTAMINATION. THEN HOW IS MY OBSERVED LAB TESTED UA COME NEGATIVE WHILE PATCH IS POSITIVE. PHARMCHEK DRUG SWEAT PATCH NEEDS TO HAVE MANDATORY SECONDARY TESTING INCLUDED, 40% FALSE POSITIVE IS TOO HIGH OF A STATISTIC TO IGNORE. THIS COMPANY PHARMCHEK DRUG SWEAT PATCH KNOW ABOUT THIS AND AREN¿T DOING ANYTHING ABOUT IT. IF YOU ARE ON A PHARMCHEK DRUG SWEAT PATCH MAKE SURE YOU ARE HAVING AT LEAST 3 UAS THAT ARE OBSERVED AND ARE LAB TESTED DURING THE TIME THE PATCH IS ON YOUR BODY. PROTECT YOURSELF LEARN ABOUT THIS COMPANY. I DO HAVE ALLERGIES BUT WITH ALL MY TESTING THE MEDICATIONS I WAS TAKING DID NOT AFFECT IT. THAT DOESN¿T MEAN YOUR MEDS DO NOT AFFECT THE RESULTS. ALWAYS SUBMITTED YOUR DRUG LIST TO THE COMPANY. REFERENCE REPORTS: #MW5149803, #MW5149805, #MW5149806.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
949827 PHARMCHEK DRUG SWEAT PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

Patients

Seq Age Sex Outcome Treatment
1 38 YR Female Life Threatening| R| O