BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XMAX-V3 PRO HERB AND WAX VAPORIZER

    MDR report key: 16701675 · Received April 6, 2023

    Report

    Report Number
    MW5116456
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 6, 2023
    Manufacturer
    UNKNOWN
    Product Code
    QLI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TONGUE, UPPER PALATE, THROAT AND LUNGS. HE DID NOT GO TO THE HOSPITAL FOR TREATMENT BUT SAYS THAT HE IS STILL EXPERIENCING PAIN IN HIS MOUTH, JAW AND FACE. PATIENT HAS A HISTORY OF BURNING MOUTH SYNDROME AND TEMPOROMANDIBULAR JOINT AND MUSCLE DISORDER (TMJ). LAST NIGHT'S INCIDENT EXACERBATED HIS SYMPTOMS OF BOTH AFOREMENTIONED MEDICAL PROBLEMS. PATIENT EXPRESSED THAT THIS DEVICE HAS NO WARNINGS ON THE INSTRUCTION/PACKAGE ABOUT THE POSSIBILITY OF BURN OR POSSIBLE INJURIES. THE DEVICE ALSO DOES NOT HAVE A SERIAL OR LOT NUMBER LIKE HIS PREVIOUS DEVICES HAD. PATIENT HAS BEEN USING THIS PARTICULAR VAPORIZER FOR ABOUT SIX MONTHS BEFORE THIS HAPPENED. HE REACHED OUT TO THE COMPANY THROUGH REDDIT AND WAS RUDELY TOLD IT WAS A RESULT OF THE WAY HE USED IT. PATIENT HAS BEEN USING VAPORIZERS FOR TEN YEARS FOR MEDICAL AND HEALTH ISSUES (PRESCRIPTION CANNABIDIOL [CBD]) AND HAS NEVER HAD THIS HAPPEN BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440705 XMAX-V3 PRO HERB AND WAX VAPORIZER VAPORIZER, CDER OR CBER LED QLI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other PRESCRIPTION CBD.