TULA TULAKIT2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840128600023), received between Jun 10, 2024 and Oct 15, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE IONTOPHORESIS STARTED WITH THE TULA KIT SIZE 2 EARPLUGS THAT WERE TOO SMALL, THUS, THE EARPLUGS WERE SWAPPED TO SIZE 3. THE IONTOPHORESIS PROCEEDED FOR 3 MINUTES AND THE SPEED WAS REDUCED UPON PATIENT DISTRESS. THE PATIENT CALMED DOWN AFTERWARD AND THE IONTOPHORESIS PROCEEDED UNTIL COMPETITION WITH NO COMPLICATIONS. THE DOCTOR PROCEEDED WITH THE TUBE INSERTION AND UPON MAKING CONTACT WITH THE TYMPANIC MEMBRANE THE PATIENT SCREAMED IN PAIN. THE DOCTOR WAS UNABLE TO TRY TO DEPLOY THE TUBE AND THE PARENTS OPTED TO FINISH THE PROCEDURE IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20450971 ↗
• InjuryOct 15, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S EAR WAS THOROUGHLY CLEANED PRIOR THE IONTOPHORESIS WITH THE TULA KIT. THE IONTOPHORESIS WAS SETUP AND COMPLETED WITHOUT ANY COMPLICATIONS. AS THE DOCTOR MADE CONTACT WITH THE TYMPANIC MEMBRANE THE PATIENT SCREAMED IN PAIN AND WOULD NOT LET THE DOCTOR HAVE A SECOND TRY, THEREFORE, THE PARENTS OPTED TO FINISH THE PROCEDURE IN THE OR. THE PARENT MADE A COMMENT AFTERWARD ASKING IF IT WAS LIDOCAINE THAT WAS USED TO NUMB THE AREA BECAUSE THE PATIENT WAS MOSTLY NON-RESPONSIVE TO LIDOCAINE AND RECENTLY HAD A PROCEDURE WITH LIDOCAINE INJECTIONS AND THE LIDOCAINE INJECTIONS WERE LARGELY INEFFECTIVE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20450911 ↗
• InjuryOct 15, 2024Premature Activation; Therapeutic or Diagnostic Output Failure; Premature Activation; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S EAR WAS THOROUGHLY CLEANED PRIOR THE IONTOPHORESIS WITH THE TULA KIT. THE IONTOPHORESIS WAS STARTED AND COMPLETED WITHOUT COMPLICATIONS. AS THE DOCTOR MADE CONTACT WITH EAR DRUM THE PATIENT SCREAMED IN PAIN. THE DOCTOR ATTEMPTED TO DEPLOY THE TUBE QUICKLY AND MADE A MYRINGOTOMY BUT THE TUBE DID NOT PENETRATE THE TYMPANIC MEMBRANE. THE TUBE WAS RETRIEVED. THE PATIENT CALMED DOWN ENOUGH TO ALLOW THE DOCTOR TO TRY AGAIN BUT AS SOON AS HE MADE CONTACT WITH THE TYMPANIC MEMBRANE AGAIN THE PATIENT SCREAMED AND WOULD NOT ALLOW FOR TUBE DEPLOYMENT. THEREFORE, THE PARENT'S OPTED TO FINISH THE PROCEDURE IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 20450846 ↗
• InjuryJun 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BILATERAL TYMPANOSTOMY, WHILE USING THE TULA KIT, THE PATIENT WAS HAVING A HARD TIME WITH IONTOPHORESIS, THE DOCTOR AND THE PARENTS TRIED TO CALM THE PATIENT WITHOUT SUCCESS, THUS, THE PROCEDURE WAS CANCELED AND SCHEDULED FOR THE OPERATING ROOM DUE TO BEHAVIORAL ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Emotional Changes

  MAUDE report 19499068 ↗