GN ReSound 21165020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296177059), received between Jul 20, 2022 and Jul 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT COMPLAINS OF AN ALLERGIC REACTION IN THE FORM OF A RASH. THE PATIENT REPORTS PERSISTENT (LASTING OVER SEVERAL MONTHS AND STARTED A FEW DAYS AFTER FIRST USE) SKIN REACTION WITH REDNESS, IRRITATION AND WETNESS ON BOTH EARS ON THE EXTERNAL PARTS OF THE EARS, AND THE SKIN REACTION HAS SPREAD TO THE FOREHEAD. THE PATIENT WAS IN CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER. IT HAS BEEN REPORTED THE AREA COULD HAVE BEEN EXPOSED TO OTHER CHEMICALS, WHICH MIGHT BE RESPONSIBLE. THE HCP IS TRYING TO FIND OUT THE ROOT CAUSE AND HAS RECOMMENDED TO USE ANOTHER HEARING AID. NO KNOWN HISTORY OF ALLERGIES OR HYPERSENSITIVITY.

  Patient problems: Rash; Skin Discoloration

  MAUDE report 15062805 ↗