GN ReSound RE5ITC-DW-MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296174546), received between Oct 7, 2021 and Oct 7, 2021 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT HAD AN SKIN ALLERGIC REACTION TO THE CUSTOM AIDS THEY HAD PURCHASED. THERE DOES NOT APPEAR TO BE ANY LASTING EFFECTS, JUST A TEMPORARY SKIN REACTION. IT DID NOT TAKE VERY LONG FOR THE REACTION TO OCCUR - MAYBE A FEW HOURS. WHEN THE ALLERGIC REACTION WAS ALSO TESTED ON THE FOREARM TO SEE IF IT WAS A TRUE ALLERGIC REACTION, IT ONLY TOOK A COUPLE HOURS FOR THE REACTION TO SHOW UP ON THE FOREARM, SO THE REACTION ON THE EARS WAS MOST LIKELY AROUND THE SAME TIME. PATIENT HAD REACTIONS IN BOTH EARS AFTER WEARING FOR A FEW HOURS. MEDICAL PROFESSIONAL HAD THE ALLERGIC REACTION TESTED ON ANOTHER PART OF THE BODY AND ALSO PRESCRIBED MEDICATION (TRIAMCINOLONE CREAM) TO RESOLVE SYMPTOMS. MEDICAL PROFESSIONAL ALSO GAVE A DIAGNOSIS OF POLYCHONDRITIS, WHICH THE PHYSICIAN FEELS IS ALSO PLAYING A PART IN THE SITUATION. SYMPTOMS: REDNESS, ITCHING, INFLAMMATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12588020 ↗