GN ReSound 20419976Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296194506), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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 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.

• InjuryNov 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: PATIENT'S EAR CANALS "RED, SWOLLEN" AFTER WEARING ONE HAS. PATIENT HAS WORN RESOUND RIC MFI HAS PREVIOUSLY W/O ANY PROBLEMS. HE LOST HIS HAS BEFORE COMING TO THIS CLINIC, SO (B)(6) HAS NO INFO ABOUT THEM. FIT W/ RT961CS, #3 HP RECEIVERS, SF3 TULIP DOMES. AFTER A FEW DAYS, PATIENT REPORTED THAT R EAR CANAL WAS "RED, SWOLLEN". STOPPED WEARING HAS. WENT TO A CLINIC, GOT DROPS & AMOXICILLIN. R CANAL CLEARED UP. STARTED WEARING HAS AGAIN. LEFT MSG FOR (B)(6) THAT, AFTER 6 DAYS, BOTH EAR CANALS ARE NOW RED, SWOLLEN & HE HAS JAW PAIN. PT REPORTS THAT HE HAS NO ALLERGIES TO LATEX OR SILICON. I WILL F/U W/ CUSTOMER BY EMAIL. COMPLAINT CREATED.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Skin Irritation

  MAUDE report 10776556 ↗