GN ReSound 21263705Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296181636), received between Oct 28, 2020 and Oct 28, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: PT. HEARD ONE "LOUD POP" - DAUGHTER WAS NEARBY AND REMOVED AID FROM PT'S EAR. DAUGHTER LIVES WITH PT AND SAID SHE COULD HEAR THE POP, ALSO. APPARENTLY HAPPENED FIRST THING IN THE MORNING WHEN PT GOT UP FOR COFFEE, AND HASN'T OCCURRED SINCE. DAUGHTER PROVIDED THE DETAILS FOR THIS CASE & SAID THAT IT WAS PAINFUL FOR HER MOM, BUT DIDN'T CAUSE ANY LASTING EFFECTS, NOR DID SHE SEE A DOCTOR FOR IT. AID WILL BE SENT IN AND NEEDS TO BE ROUTED TO Q.E. WILL DISCUSS WITH HER ISR ABOUT SENDING OUT A REPLACEMENT EQ788, AND HCP IS FITTING HER WITH A LOANER. COMPLAINT CREATED. COMMENT BY CORPORATE QUALITY: WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT. FINAL REPORT CONCLUDSIONS CAN BE FOUND IN H10 MANUFACTURERS NARRATIVE.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10746511 ↗