BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEM PATCH

    MDR report key: 23744790 · Received December 8, 2025

    Report

    Report Number
    MW5180119
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 30, 2025
    Manufacturer
    PHARMCHEM, INC.
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON ABOUT (B)(6) A FARM CHECK KEN PATCH WAS PLACED ON MY ARM THROUGH FEDERAL PROBATION I WAS TOLD BY FEDERAL PROBATION ON HER ABOUT (B)(6) 2025 THAT I TESTED POSITIVE FOR METHAMPHETAMINE I HAVE NOT CONSUMED OR INGESTED ANY METHAMPHETAMINE OR WAS I IN CONTACT WITH ANYBODY THAT USED IT THIS PRESENTS A SUBSTANTIAL VIOLATION TO MY RIGHTS DUE TO THE ACCURACY INACCURACY OF THE PATCH A FALSE POSITIVE WAS PRODUCED. MY NAME IS (B)(6) THE TEST WAS ADMINISTERED BY THE UNITED STATES (B)(6) BY (B)(6) UNITED STATES PROBATION OFFICER. I WOULD LIKE THE RESULTS OF THIS TEST LOOKING INTO AND RETESTED BY OTHER METHODS THIS IS A SUBSTANTIAL VIOLATION OF MY RIGHTS AND PRESENTS A COST OF FREEDOM BY PRODUCING A FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157472 CHEM PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other CALCIUM.| LEVOTHYROXINE.| VITAMIN B12.| VITAMIN D.