GN ReSound 20419970Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296194445), received between Oct 6, 2022 and Oct 6, 2022 — 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 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.

• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURERS REF: (B)(4). 08SEP2022: IT WAS REPORTED THAT THE PATIENT INJURED AFTER SF3 RECEIVER TOP BREAKS OFF AND GETS LODGED IN PATIENTS EAR. THE PATIENT REPORTED THAT THE TIP AND BOTTOM HALF OF THE RECIEVER FROM THE PATIENT HEARING AID HAS COME OFF IN HIS EAR. FROM THE PICTURE IT IS CLEAR THAT THE RED PORTION OF A SF3 RECEIVER MISSING FROM HIS AID. SF3 RECIEVER SEPARATED WHEN THE PATIENT WAS WEARING IT CAUSING THE TIP TO GO DEEP IN THE PATIENT EAR CANAL PUNCTURING THE PATIENTS EAR DRUM ACCORDING TO THE PROVIDER, WHO NOTIFIED THE MANUFACTURER BY EMAIL. THE PATIENT WENT TO ER TO GET IT REMOVED AND IS NOW SEEING ENT DOCTOR. THE INCIDENT CAUSED BLEEDING AND PUNCTURED EARDRUM. 27SEP2022: FOLLOW UP INFORMATION RECIEVED. IT WAS REPORTED THAT NO DAMAGE WAS DONE TO THE PATIENTS EAR. THE ER GOT IT WRONG. THE ENT WAS ABLE TO REMOVE THE BROKEN PIECE EASILY AND WITHOUT ISSUE. NOTHING MORE SERIOUS THAN A BIT OF IRRITATION FROM THE ER DOCTORS ATTEMPTS AT REMOVING THE TIP. THIS IS A COMBINED REPORT (INITIAL AND FINAL). NO FURTHER FOLLOW UP INFORMATION IS EXPECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15549363 ↗