FDA Adverse Event Death Summary report: N

THERMAL IMAGING

MDR report key: 22467526 · Received July 10, 2025

Report

Report Number
MW5172494
Event Type
Death
Date Received
July 10, 2025
Date of Event
March 18, 2024
Report Date
July 7, 2025
Manufacturer
UNK
Product Code
LHQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

THERMAL IMAGING / FUNCTIONAL INFRARED DEVICE MISUSE - MY WIFE'S PROVIDERS REPRESENTED THERMAL IMAGING AS AN ALTERNATIVE THAT THEY COULD IDENTIFY BREAST CANCER WITH THEIR THERMAL IMAGING USE AND DID NOT ADVISE THAT THERMAL IMAGING IS ONLY AN ADJUNCTIVE METHOD. WEBSITE ((B)(6) IS THE OWNER - (B)(6)) STATES "WELCOME TO (B)(6) LEADING HEALTHCARE IMAGING SERVICE. WE SPECIALIZE IN AN INNOVATIVE, SAFE ALTERNATIVE TO CONVENTIONAL BODY IMAGING AND HEALTH SCREENINGS. OUR PERSONAL AND PROFESSIONAL SERVICES PROVIDE DIVERSE BODY IMAGING CHOICES FOR MEN, WOMEN, AND CHILDREN; A FULL BODY SCAN, A PARTIAL BODY SCAN OR BREAST IMAGING. THERMOGRAPHY IS A RELIABLE METHOD TO DETECT THE SIGNS OF HEALTH CONDITIONS BEFORE THEY BECOME A PROBLEM ALLOWING YOU TO MAKE CHANGES THAT WILL HELP YOUR BODY HEAL." REPORT FROM (B)(6) 2024, VISIT SHOWED SHE WAS AT RISK OF DEVELOPING AGGRESSIVE TISSUE, BUT DID NOT INDICATE SHE HAD ANY AGGRESSIVE TISSUE. NO REFERRAL WAS MADE. I HAVE SIGNIFICANT DOCUMENTATION. ON THE REPORTS, THE "READER" IS (B)(6). HE CONSULTED WITH MY WIFE ON THE IMAGING RUN BY (B)(6). I FOUND OUT AFTER THE FACT THAT HE WAS PREVIOUSLY WARNED IN CONJUNCTION WITH (B)(6) IN 2019 BY THE FDA ABOUT THEIR MISUSE OF THERMAL IMAGING. (B)(6) WERE THE SUBJECT OF ABC'S GOOD MORNING AMERICA, NIGHTLINE, AND ONLINE ARTICLES FOR THEIR MISUSE OF THERMAL IMAGING. (B)(6) DOCTOR OF CHIROPRACTIC LICENSE WAS PULLED BY STATE OF (B)(6) IN 2023 BECAUSE OF HIS VIOLATIONS. HE STILL KEPT THE (B)(6) INITIALS ON THE REPORTS PROVIDED TO MY WIFE IN 2024. HE ALSO REPRESENTED HIMSELF AS A FUNCTIONAL MEDICINE DOCTOR AND (B)(6), HE, AND HIS OTHER COLLEAGUES ALL REFER TO HIM AS "DOCTOR" IN THEIR COMMUNICATIONS TO MY WIFE. WE BECAME ESPECIALLY AWARE OF THEIR INCOMPETENCE AFTER A FOLLOW-UP SCAN FOR (B)(6) 2024, SHOWED MASSIVE CHANGES TO THE BREAST AND (B)(6) RECOMMENDED FOLLOWING UP IN ANOTHER YEAR. PDFS OF REPORTS CAN BE PROVIDED. HORRIFIC MISDIRECTION AND MINIMIZATION OF SYMPTOMS PROVIDED. BREAST CANCER METASTASIZED BECAUSE OF THIS AND KILLED HER ON (B)(6) 2024.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1316525 THERMAL IMAGING SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) LHQ UNK

Patients

Seq Age Sex Outcome Treatment
1 38 YR Female Disability| H| D