Beltone 19962900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819291462), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  WE HEREBY FORWARD A MIR REPORT RE. AN INCIDENT IN (B)(6): ALLERGIC REACTION REPORTED BY DISPENSER. PATIENT SYMPTOM: DERMATOLOGIC IRRITATION (HEAD AND NECK) TIME OF USE BEFORE SYMPTOM APPEARED: THE REACTION APPEARED WITHIN THE FIRSTS WEEKS AND LASTED FOR THE TIME THE DEVICES WERE WORN BY THE PATIENT. THE SKIN REACTION HAS BEEN CONFIRMED BY DOCTOR (SUMMARY REPORT ATTACHED TO THE CASE). ACCORDING TO THIS REPORT, THE REACTION IS CAUSED BY THE MATERIALS USED TO PRODUCE THE DEVICE AS THE TREATMENT PRESCRIBED (NOT SPECIFIED) DID NOT PRODUCE THE EXPECTED RESULTS WHILE HE PATIENT WORE THE DEVICES, BUT THE PATIENT GOT SIGNIFICANTLY BETTER WHEN SHE STOP WEARING THE INSTRUMENTS. ALTHOUGH IT IS NOT SPECIFIED IN THE REPORT, ACCORDING TO THE CONVERSION WITH THE DISPENSER, THE DOCTOR THINKS THE REACTION WAS CAUSED BY THE NANO COATING TREATMENT (17369900 NANO COATING, ARIDION 120 C1). THE PATIENT DOES NOT HAVE A PREVIOUS HISTORY OF ALLERGIC REACTIONS, ALTHOUGH ACCORDING TO THE CONVERSATION WITH THE DISPENSER, SHE HAS A "VERY SENSITIVE" SKIN. ENVIRONMENT: ACCORDING TO THE INFORMATION PROVIDED BY THE DISPENSER, THE REACTION DOES NOT SEEM TO BE CAUSED BY WEARING THE DEVICE IN A SPECIFIC ENVIRONMENT (H

  Patient problems: Skin Irritation

  MAUDE report 10458790 ↗