TULA IOCNTRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840128600146), received between Feb 10, 2022 and Jan 15, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Unexpected Shutdown” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IN-OFFICE BILATERAL TULA PROCEDURE, THE SURGEON FACED DIFFICULTY TO FIND A PROPER SEAL ATTEMPTING TO USE TWO (2) EARPLUGS SIZE 2, 3 AND ONE (1) EARPLUG SIZE 4. IONTOPHORESIS WAS COMPLETED SUCCESSFULLY WITH NO ALARMS; HOWEVER DURING THIS STAGE OF THE PROCEDURE THE PATIENT COMPLAINED ABOUT DISCOMFORT AND PAIN; WHICH LEAD TO USE REDUCE MODE. LATER ON THE SURGEON DEPLOYED SUCCESSFULLY THE TDS ON THE LEFT EAR; HOWEVER THE PATIENT COMPLAINED OF DISCOMFORT AND PAIN ON THE RIGHT EAR. THE PROCEDURE WAS RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 18512357 ↗
• InjuryFeb 10, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A TYMPANOSTOMY PROCEDURE, THE CONTROL UNIT FAILED. THE FAULT LIGHT (RED) ILLUMINATED UPON REMOVAL OF THE ACTIVATION TAB. NO BACKUP DEVICE WAS AVAILABLE, SO THE SURGEON USED PHENOL TO NUMB THE EARS AND THEN CONTINUED WITH THE USE OF THE TULA TUBES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509349 ↗