TULA 72290097Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556817742), received between Sep 25, 2024 and Oct 31, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Premature Activation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, ONE (1) TULA TDS DEPLOYED THE TUBE PREMATURELY. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS FINE WITH AN OR PLACED TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442205 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER AN UNLITERAL TYMPANOSTOMY ON (B)(6) 2024. THE PATIENT HAD A FOLLOW-UP VISIT. DURING THE POST OP EXAM, IT WAS OBSERVED THAT THE TUBE HAD MEDIALIZED, THOUGH THE EXACT TIME WAS UNCLEAR. THE PATIENT HAS BEEN SCHEDULED FOR A TUBE RETRIEVAL IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261140 ↗
• InjurySep 25, 2024Premature Activation; Unexpected Shutdown; Premature Activation; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, DURING THE IONTOPHORESIS, THE SURGEON DOUBLE CLICKED ON BOTH CHANNEL BUTTONS TO ENTER "REDUCE MODE" AND THE FAULT INDICATOR LIT UP AND THE CONTROL UNIT STOPPED WORKING. THE SURGEON INSISTED TO USE ANOTHER CONTROL UNIT AND UTILIZED A SPARE TO COMPLETE THE IONTOPHORESIS. AFTER IT WAS COMPLETED, THE SURGEON DEPLOYED THE TUBE DELIVERY SYSTEM IN WHICH A "SHORT SHOT" OCCURRED. THE SURGEON PROMPTLY REMOVED THE TUBE FROM THE EAR CANAL, AND UTILIZED A REPLACEMENT TDS DEVICE. THEY TRIED TO MOVE ON TO THE NEXT EAR AND DUE TO THE PATIENT´S TEMPERAMENT, THE PROCEDURE WAS ABORTED AND RE-SCHEDULED IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20301458 ↗