TULA EP1PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840128600078), received between Dec 7, 2021 and Dec 7, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Premature Activation” (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.

• InjuryDec 7, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, THE TULA EARPLUG SIZE 1 HAS TO BE REPLACED BECAUSE THERE WAS A LEAK. THE PATIENT WOULDN'T SIT STILL, THE PHYSICIAN HAD 2 SHORT SHOTS ON THE RIGHT EAR AND 1 ON THE LEFT EAR. AFTER THE SHORT SHOT ON THE LEFT SIDE, THE DOCTOR SCHEDULED THE PATIENT FOR THE OR. THERE WAS NO PATIENT INJURIES BUT THE PROCEDURE WAS NOT SUCCESSFUL AS IT WAS NOT POSSIBLE TO HOLD THE PATIENT STILL LONG ENOUGH TO GET PROPER APPOSITION TO THE TM. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Anxiety

  MAUDE report 12957378 ↗