BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHARMCHEK SWAET PATCH

    MDR report key: 22896913 · Received August 26, 2025

    Report

    Report Number
    MW5175234
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    March 19, 2025
    Report Date
    August 21, 2025
    Manufacturer
    PHARMCHEM, INC.
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    "PRESENT/PRESENCE" - ACCORDING TO CRL/PHARMCHEK THIS AIDS IN A "POSITIVE TEST", HOWEVER, BY SCIENTIFIC DEFINITION IT IS NEGATIVE (BELOW LOQ; 10NG), HOWEVER, SIMPLY BECAUSE CRL CHOOSES TO USE A MORE [INVALID] NT LEVEL FOR RUNNING THEIR ANALYSIS AND THOSE LEVELS SHOW PRESENT, IT MAKES IT APPEAR THEY THEN REPORT POSTIVE. DR. (B)(6) OFTEN TESTIFIES TO THESE RESULTS AND DOES NOT GIVE PROPER INSIGHT. HARMFUL ERROR EXISTS... THEIR INTENTIONAL EFFORTS TO MISLEAD BEGINS WITH THE LACK OF TRANSPARENCY ON THE CRL LAB RESULTS WHICH PHARMCHEK USES TO ANALYZE THEIR PATCHES. MAJORITY OF THE LIMITED STUDIES THAT WERE ALLOWED TO PUBLICATION AND VIEWED BY PUBLIC EXUDES THE SAME LACK OF TRANSPARENCY AND SAME IMMENSE AMOUNT OF CONFUSION FOR INTERPRETING THE RESULTS PRODUCED IN THESE EXPERIMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379851 PHARMCHEK SWAET PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention