BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHARMCHEK DRUG PATCH

    MDR report key: 8604576 · Received May 10, 2019

    Report

    Report Number
    MW5086566
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    September 1, 2018
    Report Date
    December 11, 2018
    Manufacturer
    PHARMCHEM, INC.
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT PROBLEM WITH HER PHARMCHEK DRUG PATCH. PT STATED THAT SHE WEARS THE PATCH FOR DRUG USE TESTING, AND SHE HAS RECEIVED FALSE POSITIVE RESULTS WHEN SHE WAS NOT USING DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391823 PHARMCHEK DRUG PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR