TULA 72290098Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556817759), received between Oct 21, 2024 and Dec 16, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, FOUR (4) EARPLUGS, SIZE 2 , DID NOT STAY IN EAR CANAL. THE RIGHT SIDE STARTED WITH A SIZE 3, BUT UPON FAILURE A SIZE 2 WAS TRIED BUT SINCE IT FAILED A SIZE 3 WAS TRIED AGAIN. THE EARPAD WAS USED PROPERLY AND SEEMED TO BE WORKING UNTIL A LEAK OCCURRED LESS THAN A MINUTE INTO IONTOPHORESIS. AFTER THAT LEAK, IT WAS UNABLE TO MAINTAIN EAR PLUG STABILIZATION AND TRIED BOTH SIZES 2 AND 3 IN THE CANAL. THE CANAL WAS DRIED EACH TIME BEFORE REPLACING THE PLUG AND FILLING. THE CHILD WAS CRYING AND FIDGETING WHICH EVENTUALLY LED TO THE EARPAD FAILING. ALCOHOL WAS USED TO CLEAN THE EAR CANAL PRIOR TO THE FINAL ATTEMPT ON THE RIGHT SIDE. WITHOUT THE EARPAD IN PLACE, THE EARPLUG SIMPLY POPPED OUT. THE LEFT SIDE WAS STARTED WITH A SIZE 3 WHICH STABILIZED LONGER ON THIS SIDE AS IT ONLY HAD 2 ALARMS. AFTER THE FIRST ALARM, IT WAS REPLACED WITH A SIZE 2. THE SIZE 2 WAS TOO SMALL SO QUICKLY IT WENT BACK TO SIZE 3. THE SIZE 3 MAINTAINED STABILIZATION ON THIS SIDE WELL INTO THE 3RD PHASE OF IONTOPHORESIS AND THE CHILD MANUALLY PULLED IT OUT. UPON RECEIVING THE SECOND ALARM IN THE 3RD PHASE, THE SPECIALIST CHOSE NOT TO PROCEED AS THE RIGHT SIDE WAS NOT SEATING

  Patient problems: Discomfort

  MAUDE report 20938935 ↗
• InjuryOct 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE TULA GEN 2 ROTATING ARM WAS DEFECTIVE. THE ROTATING ARM WAS MEANT TO HOLD COUNTER PRESSURE TO HELP HOLD THE EAR PLUG IN PLACE, HOWEVER, THERE WAS SIGNIFICANT PATIENT MOVEMENT AND THE ROTATING ARM CAME LOOSE TOO EASILY AND IT ENDED UP BECOMING AN HINDRANCE. THE PATIENT GOT SWEATY WHEN GOT WORKED UP AND CRIED, THUS, THE ADHESIVE ON THE PIECE THAT ADHERES TO THE NECK OFTEN CAME OFF AND LOOSE ITS STICKINESS TO THE PATIENTS SWEATY SKIN, BECOMING INEFFECTIVE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 20495029 ↗