TULA 72290090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556817674), received between Aug 20, 2024 and Oct 10, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, THE IONTOPHORESIS WITH A TULA KIT WAS UNSUCCESSFUL DUE TO THE PATIENT'S TYMPANIC MEMBRANE BEING TOO THICK, AND COULD NOT BE ANESTHETIZED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT DID NOT RECEIVED THE TULA TUBES AT THE MOMENT; HOWEVER, IT WAS RESCHEDULED AND SUCCESSFULLY PERFORMED IN THE OR THE FOLLOWING WEEK. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23272730 ↗
• MalfunctionAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S FATHER BELIEVED THE CHILD WAS HAVING AN ALLERGIC REACTION DURING IONTOPHORESIS. THE CHILD'S FOREHEAD WAS RED, AND THE PARENTS WERE CONCERNED. THE PHYSICIAN CAME IN TO ADDRESS THE SITUATION, EXAMINED THE CHILD, ASKED THE PARENTS SOME FAMILY HISTORY QUESTIONS, AND ULTIMATELY ABORTED THE PROCEDURE OUT OF AN ABUNDANCE OF CAUTION AND RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22727008 ↗
• MalfunctionMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY USING A TULA KIT, THE PATIENT WAS NO LONGER DEEMED A GOOD CANDIDATE FOR A TULA PROCEDURE DUE TO TEMPERAMENT. THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO HAVE SURGERY IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562503 ↗
• InjuryJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY USING A TULA KIT, THE PATIENT WAS NO LONGER DEEMED A GOOD CANDIDATE TO USE THE TULA SYSTEM DUE TO PATIENT TEMPERAMENT. THE PROCEDURE WAS ABORTED AND RESCHEDULED TO HAVE SURGERY IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 21218426 ↗
• InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, WHEN THE TULA KIT BILATERAL WAS OPENED, THE SURGEON MADE THE CLINICAL DETERMINATION THAT THE PATIENT WAS NOT A GOOD FIT FOR THE PROCEDURE DUE TO PATIENT TEMPERAMENT, THUS, THE PROCEDURE WAS ABORTED AND RE-SCHEDULE FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 20301406 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY WHILE USING THE TULA KIT, THE SPECIALIST NO LONGER DEEMED THE PATIENT A GOOD CANDIDATE TO USE THE TULA SYSTEM DUE TO PATIENT TEMPERAMENT. THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO SURGERY IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Emotional Changes

  MAUDE report 20009015 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY WHILE USING THE TULA KIT, THE SPECIALIST NO LONGER DEEMED THE PATIENT A GOOD CANDIDATE TO USE THE TULA SYSTEM DUE TO PATIENT TEMPERAMENT. THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO SURGERY IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Emotional Changes

  MAUDE report 20004622 ↗