BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHARMCHEK SWEAT PATCH

    MDR report key: 8541181 · Received April 22, 2019

    Report

    Report Number
    MW5086068
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    May 12, 2018
    Report Date
    April 18, 2019
    Manufacturer
    PHARMCHEM, INC.
    Product Code
    FMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE OF SWEAT PATCH BY PHARMCHEM. STATE SEIZURE OF CHILDREN. CASE PLAN REQUIRED BY STATE UNTIL PROOF NO SAFETY RISK OR DRUG USE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331499 PHARMCHEK SWEAT PATCH CONTAINER, SPECIMEN, STERILE FMH PHARMCHEM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R