GN ReSound 21435508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296189953), received between Sep 21, 2021 and Sep 21, 2021 — 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.

• InjurySep 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: HCP REPORTED PT PREVIOUSLY HAD AN EAR INFECTION IN THE LEFT EAR DUE TO DOME. HCP STATED SHE SAW PT IN (B)(6) 2020 AND NO ISSUES WERE NOTED AT THAT TIME. ON (B)(6) 2020, HCP PLACED A MEDICAL REFERRAL DUE TO REDNESS, BLOOD AND DISCHARGE IN LEFT EAR. PT WAS WEARING A SMALL POWER DOME AT THE TIME. HCP SAID PT WAS TOLD TO TAKE IT EASY BECAUSE HE PUTS THE DOME IN FAR. PT'S SON IS A DOCTOR AND PRESCRIBED HIM EAR DROPS. HCP SAID PT WAS CLEARED BY AN ENT PER STORE'S CHART NOTES ON (B)(6) 2020. THAT WAS PT'S FIRST EAR INFECTION. PT NOTED SOME WHITE DISCHARGE, BUT ENT REPORTEDLY INFORMED HIM IT WAS WAX. PT NOW USES A CUSTOM EARMOLD. HE FIRST TRIED A SILICONE MOLD, BUT NOW HCP SAID PT HAS AN ACRYLIC MOLD. ADDITIONAL INFORMATION: SYMPTOMS: REDNESS, PAIN, INFECTION, EAR DISCHARGE/FLUID.

  Patient problems: Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 12504580 ↗