BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHARMCHEK SWEAT PATCH

    MDR report key: 16787171 · Received April 20, 2023

    Report

    Report Number
    MW5116870
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    February 17, 2023
    Report Date
    April 18, 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

    I HAVE HAD MULTIPLE PATCHES COME BACK FALSE POSITIVE. I TAKE ALLERGY MEDS THAT SHOW POSITIVE METH USE BUT ONCE MY MEDICATION LIST WAS SUBMITTED WITH THE ACTUAL PATCH TO THE LAB, I NO LONGER WAS SHOWING POSITIVE. I AM NOW GETTING 3 PATCHES RETESTED BUT THE HEAD OF THE LAB SAYS MY MEDICATION LIST DOESN'T MATTER WHEN HIS OWN LAB HAS PROVEN IT WRONG. I HAVE HAD 5 PATCHES ALL TOGETHER. CURRENTLY ON PATCH NUMBER 7 ONE PATCH AT THE LAB. THIS IS FOR CHILD PROTECTION CASE WHERE MY CHILDREN HAVE BEEN TAKEN BECAUSE THE COUNTY THINKS I'M USING BECAUSE THE 1ST 3 PATCHES WERE NOT TESTED CORRECTLY. IF WHAT (B)(6) (LAB TOXICOLOGIST) SAYS IS TRUE, THAT THEY DON'T NEED THE MEDICATION LIST THEN I SHOULD HAVE NEVER HAD THE FALSE POSITIVES. PATCH 4 I TOOK NO MEDS, PATCH 5 I SUBMITTED MY MEDICATION LIST CAME BACK NEGATIVE. I ALSO PAID FOR MY OWN PATCH OUT OF THE COUNTY FROM A DIFFERENT LAB ALSO SUBMITTED MY MEDICATION LIST AND MY PATCH CAME BACK NEGATIVE. MEDICATION (NUMBER 14 ON CHAIN OF CUSTODY FORM) SHOULD NOT BE OPTIONAL. MY PATCHES HAVE PROVEN THIS FACT. THESE PATCHES CONTROL A LOT OF WHAT HAPPENS TO PEOPLE'S LIVES (JAIL TIME, OR REMOVAL OF CHILDREN FROM PARENTS¿ LIVES) LAB DIRECTOR (B)(6) AND TOXICOLOGIST (B)(6) NEED TO FIGURE OUT THEIR LAB BECAUSE THESE PATCHES EFFECT GOOD PEOPLE'S LIVES. REFERENCE REPORTS MW5116869, MW5116871.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363309 PHARMCHEK SWEAT PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other MONTELUKAST SOD 10MG DAILY, DELSYM 12 HRS AS NEEDED, ALEVE D 220MG AS NEEDED, IBUPROFEN 200MG AS NEEDED, LORATADINE 10 MG DAILY, FEXOFENADINE 180 MG DAILY, BENADRYL PLUS CONGESTION DAILY, SYMBICORT(INHALER) AS NEEDED, ALBUTEROL(INHALER) AS NEEDED.