Anodyne Therapy 300Recalls & reported problems
Anodyne Therapy, L.L.C. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859101006059), received between Jun 1, 2022 and Jun 1, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2022Use of Device Problem
EXACERBATION OF PAIN; I SAW DR (B)(6) ON (B)(6) 2022 AT HIS OFFICE ON (B)(6). I HAVE CHRONIC PAIN FROM PERIPHERAL NEUROPATHY IN MY FEET. DR. (B)(6), I LATER FOUND OUT IS NOT DOCTOR ONE OF THE FIRST OF MANY MISREPRESENTATIONS, HE IS A CHIROPRACTOR. DR. (B)(6) PROPOSED A THERAPY INVOLVING A DEVICE REBUILDER MODEL 300 AND ANODYNE THERAPY MODEL 300 TO PURPORTEDLY STIMULATE NERVE GROWTH AND REDUCE MY PAIN ALONG WITH SUPPLEMENTS. IT IS ELECTRO THERAPY AND INFRARED LIGHT. HE EXPLAINED THAT I COULD TRY THIS FOR A MONTH AND CANCEL IF IT DID NOT WORK. AFTER THE FIRST DAY I WAS IN HORRIFIC PAIN AND ALSO FOUND OUT THAT THE SUPPLEMENTS WERE MADE OF GRAIN ALCOHOL. I HAVE LIVER ISSUES THAT WERE DISCLOSED DURING INTAKE. I STOPPED THE THERAPY IMMEDIATELY AND STARTED TO REVIEW THE DEVICE AND THERAPY. IT IS A SCAM AND THERE IS ZERO CLINICAL EVIDENCE DEMONSTRATING ANY VALUE WHATSOEVER. "DR." (B)(6) IS ENGAGED IN DECEPTIVE ADVERTISING, MISPRESENTING CLINICAL INFORMATION AND DEFRAUDING PEOPLE IN SEVERE PAIN. THERE ARE MULTIPLE WARNINGS ON THE WEB THAT I LATER FOUND SPECIFICALLY WARNING THAT THIS DEVICE IS NOT INTENDED OR NOR APPROVED FOR PERIPHERAL NEUROPATHY. HOWEVER DR. (B)(6) IS ABSOLUTELY MARKETING
Patient problems: Pain
MAUDE report 14576024 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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