BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEAT PATCH

    MDR report key: 21911648 · Received April 25, 2025

    Report

    Report Number
    MW5169523
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 13, 2025
    Report Date
    April 24, 2025
    Manufacturer
    PHARMCHEM, INC.
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALL RECEIVED FROM REPORTER WITH COMPLAINT OF FALSE-POSITIVE READINGS FROM THE SWEAT PATCH WHICH IS A DEVICE USE FOR METHAMPHETAMINE DRUG TESTING. THE REPORTER STATED THAT HER DAUGHTER HAS BEEN IN TREATMENT SINCE (B)(6) 2025 AND HAS NOT USED ANY DRUGS FOR MONTHS. HER DAUGHTER'S CHILDREN (12-YEAR-OLD AND 15-MONTH-OLD) WERE TAKEN AWAY TO FOSTER CARE ON (B)(6) 2025. REPORTER STATED THAT HER DAUGHTER'S URINALYSIS SHOWS NO DRUGS IN HER DAUGHTER'S SYSTEM, BUT THE PATCHES KEEP COMING UP POSITIVE. REPORTER STATED THAT DRUG TESTING SOLUTIONS IS THE COMPANY THAT SENDS THE PATCHES FOR TESTING WHERE, THERE IS A LONG PERIOD OF TIME BETWEEN THE TEST DATE AND WHEN THE PATCHES ARE RECEIVED FOR THE TESTING AND WAS WONDERING IF THIS MIGHT CAUSE A PROBLEM WITH RESULTS. THE FAMILY HAS BEEN TRYING TO GET CUSTODY OF THE CHILDREN BUT TO DATE, HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428353 SWEAT PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other