FDA Adverse Event Malfunction Summary report: N

DOCTOR'S DATA URINE TOXIC & ESSENTIAL ELEMENTS (PROVOKED / POST-PROVOCATION)

MDR report key: 23631484 · Received November 24, 2025

Report

Report Number
MW5179343
Event Type
Malfunction
Date Received
November 24, 2025
Report Date
November 20, 2025
Manufacturer
DOCTOR'S DATA INC.
Product Code
OIE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IA, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

HEALTH FRAUD REPORT REGARDING PROMOTION OF INVALIDATED HEAVY-METAL TESTING. (B)(6), FNP-C IN (B)(6) APPEARED ON KTVO TELEVISION (B)(6) 2025 CLAIMING 22 PATIENTS TESTED "ALARMINGLY HIGH" FOR LEAD AND CADMIUM USING DOCTOR'S DATA, INC. PROVOKED (POST-CHELATION) URINE TESTS AND IMPLIED A LOCAL POISONING ISSUE. NEWS STORY: HTTPS://KTVO.COM/NEWS/LOCAL/OTTUMWA-NURSE-SAYS-22-PATIENTS-ALL-TESTED-HIGH-FOR-LEAD-AND-CADMIUM-OVER-3-YEAR-SPAN A CHELATING AGENT IS GIVEN FIRST, ARTIFICIALLY INCREASING EXCRETION BUT RESULTS ARE GRAPHED AGAINST NON-PROVOKED REFERENCE RANGES. DOCTOR'S DATA CONCEDED IN A 2017 LEGAL SETTLEMENT: "IT IS NOT APPROPRIATE FOR A DOCTOR TO USE A PROVOKED TEST TO TELL PEOPLE THEY HAVE HEAVY METAL POISONING" AND PROVOKED TESTING "SHOULD NOT BE THE SOLE BASIS FOR RECOMMENDING CHELATION THERAPY." SETTLEMENT: HTTPS://QUACKWATCH.ORG/WP-CONTENT/UPLOADS/2017/07/DD_SUIT_SETTLEMENT.PDF AMERICAN COLLEGE OF MEDICAL TOXICOLOGY (2013): PROVOKED URINE TESTING IS NOT VALID FOR DIAGNOSIS OR SCREENING. HTTPS://WWW.ACMT.NET/_LIBRARY/POSITIONS/ACMT_POSITION_STATEMENT_-_POST_CHELATOR_CHALLENGE_URINE_METAL_TESTING.PDF THESE TESTS AND FOLLOW-UP CHELATION TREATMENTS ARE ALMOST NEVER COVERED BY INSURANCE AND COST PATIENTS HUNDREDS TO THOUSANDS OUT-OF-POCKET. I HAVE ALSO REPORTED TO (B)(6) BOARD OF NURSING, (B)(6) AG CONSUMER PROTECTION, FTC, AND CMS OIG. THANK YOU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2578048 DOCTOR'S DATA URINE TOXIC & ESSENTIAL ELEMENTS (PROVOKED / POST-PROVOCATION) URINE COLLECTION KIT (EXCLUDES HIV TESTING) OIE DOCTOR'S DATA INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown