GN Hearing 22015876Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296221981), received between Sep 21, 2021 and Sep 21, 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 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, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: HCP CALLED TO REPORT THAT A CUSTOMER HAS EXPERIENCED 3 EAR INFECTIONS SINCE HE WAS FIT WITH JABRA PM 861DRW WITH M&RIE RECEIVERS WITH POWER DOMES, AND SF3 SPORTSLOCKS. HE WAS INITIALLY FIT IN JULY 1 AND CAME IN FOR A FIRST FOLLOW-UP ON JULY 7, AT WHICH TIME HE DID NOT HAVE ANY ISSUES. THE PATIENT THEN GOT AN INFECTION IN ONE EAR. HE WENT TO THE DOCTOR AND GOT ANTIBIOTIC DROPS. THAT INFECTION CLEARED, AND THE PATIENT STARTED USING HIS INSTRUMENTS AGAIN. THE HCP STATES THAT THE PATIENT DID NOT REPORT THE FIRST OR SECOND INFECTIONS, AND THAT HE DID NOT COME IN FOR REPLACEMENT RECEIVERS AT THE TIME. SHE BELIEVES HE MAY HAVE REINFECTED HIMSELF BY GOING BACK TO USING THE SAME RECEIVER/DOMES. THE PATIENT THEN DEVELOPED INFECTION IN BOTH EARS, AND DID NOT STOP USING THE INSTRUMENTS. HIS DOCTOR ADVISED HIM TO USE ONLY ONE INSTRUMENT AT A TIME, WHILE THE OTHER EAR CLEARS. HCP IS IN THE PROCESS OF ORDERING HYPOALLERGENIC EARMOLDS. THE PATIENT DOES NOT HAVE A HISTORY OF EAR INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 12504586 ↗