BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHARMACHECK DRUG SWEAT PATCH

    MDR report key: 13783050 · Received March 15, 2022

    Report

    Report Number
    MW5108181
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    June 7, 2021
    Report Date
    March 13, 2022
    Manufacturer
    PHARMCHEM, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM REQUIRED TO TAKE DRUG TESTS AS PART OF MY CHILD ABUSE ASSESSMENT CASE AND IN (B)(6) 2021 A PATCH WAS PUT ON MY LEFT ARM. I WORKED, SWEATING AND IN THE HEAT. I NOTICED IT STARTED BURNING WHERE THE PATCH WAS ON MY SKIN. I TOLD MY WORKERS ABOUT IT AND THEY SEEM UNCONCERNED. I DO HAVE AN ALLERGY TO MEDICAL TAPE AND WHEN THIS PATCH WAS TAKEN OFF ON I WAS LEFT WITH A RED MARK THAT WAS DEEP AND IT HAS NOT GONE AWAY. I HAVE SCARRING ON MY ARM FROM THIS DEVICE AND AM STILL REQUIRED TO WEAR IT. I HAVE CONTACTED THE COMPANY ABOUT IT AND HAVE HEARD NOTHING IN RETURN. I JUST WOULD LIKE TO KNOW WHAT TO DO. PHARMACHECK DRUG SWEAT PATCH LEFT SCARRING ON MY ARM. I ALSO QUESTION THE VALIDITY OF THE PATCH AS I HADN'T BEEN USING BUT PATCHES WERE COMING UP DIRTY. I QUESTION WHETHER THEY CAN BE CONTAMINATED BY OUTSIDE FACTORS OR COLLECT SWEAT FOR LONGER PERIODS OF TIME THAN THEY SAY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42544 PHARMACHECK DRUG SWEAT PATCH CONTAINER, SPECIMEN, STERILE KGX PHARMCHEM, INC.
    42545 ADHESIVE TAPE TAPE AND BANDAGE, ADHESIVE KGX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Disability ABILIFY| DRAGONS FRUIT| LEMON BLAM| MEDICAL MARIJJUANA CARD| TRAZADONE| TUMERIC | ZINC| ZOLOFT