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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN XMAX-V3 PRO HERB AND WAX VAPORIZER; VAPORIZER, CDER OR CBER LED
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UNKNOWN XMAX-V3 PRO HERB AND WAX VAPORIZER; VAPORIZER, CDER OR CBER LED Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 04/05/2023
Event Type  Injury  
Event Description
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.
 
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Brand Name
XMAX-V3 PRO HERB AND WAX VAPORIZER
Type of Device
VAPORIZER, CDER OR CBER LED
Manufacturer (Section D)
UNKNOWN
MDR Report Key16701675
MDR Text Key313005978
Report NumberMW5116456
Device Sequence Number1
Product Code QLI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2023
Patient Sequence Number1
Treatment
PRESCRIPTION CBD.
Patient Outcome(s) Other;
Patient Age35 YR
Patient SexMale
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