TULA TYMB001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840128600139), received between Jan 19, 2022 and Jan 15, 2024 — classified as 4 injuries.

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

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

  IT WAS REPORTED THAT DURING AN IN-OFFICE TULA PROCEDURE, SURGEON FACED DIFFICULTY TO FIND A SIZE FOR AN ATYPICALLY SMALL EAR; SURGEON ATTEMPTED TO USE SIZES 4, 3, 2 AND 1 OF EARPLUGS IN ORDER TO FIND A PROPER SEAL DURING THE FILL. IONTOPHORESIS WAS COMPLETED SUCCESSFULLY WITHOUT ALARMS NOR INTERRUPTIONS; HOWEVER WHEN THE SURGEON TESTED THE TYMPANIC MEMBRANE TO DETERMINE IF IT WAS PROPERLY ANESTHETIZED UTILIZING THE TDS DEVICE, THE PATIENT COMPLAINED OF DISCOMFORT. THE PROCEDURE WAS ULTIMATELY ABORTED AND THE PATIENT RESCHEDULED FOR THE OPERATING ROOM.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 18512422 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BILATERAL TULA TUBE PLACEMENT, THE TYMBION WAS WARMED UTILIZING THE TYMBION WARMER TO DESIRED TEMPERATURE PRIOR THE PATIENT'S ARRIVAL. THE DOCTOR INSPECTED THE PATIENT'S AUDITORY CANALS AND SIZED THE PATIENT TO A EP3G EARPLUG BILATERALLY BEFORE ASSEMBLING THE BILATERAL KIT. THE PATIENT'S EAR CANALS WERE FILLED WITH TYMBION. IN THE FIRST STAGE OF IONTOPHORESIS THE PATIENT EXPERIENCED SIGNIFICANT DISCOMFORT AND THE DOCTOR SET THE CONTROL UNIT TO REDUCE MODE. THE PATIENT BECAME NON-COMPLIANT AND THE DOCTOR PAUSED THE THERAPY. AFTER A SHORT BREAK TYMBION IONTOPHORESIS WAS RESUMED ON THE PATIENT'S LEFT SIDE, WITH THE LEFT AUDITORY CANAL POSITIONED IN A VERTICAL ORIENTATION. SEVERAL LEAKS AND CONTROL UNIT ALERT LIGHTS WERE OBSERVED BEFORE IONTOPHORESIS WAS CONCLUDED SUCCESSFULLY ON THE PATIENT'S LEFT SIDE. THE DOCTOR THEN REPOSITIONED THE PATIENT AND RESUMED IONTOPHORESIS ON THE PATIENT'S RIGHT SIDE WITH THE RIGHT AUDITORY CANAL POSITIONED IN A VERTICAL ORIENTATION. IONTOPHORESIS WAS CONCLUDED SUCCESSFULLY ON THE PATIENT'S RIGHT SIDE. THE DOCTOR OBSERVED THE ANTERIOR-INFERIOR QUADRANT OF THE TYMPANIC MEMBRANE OF THE PATIENT'S RIGHT EAR UNDER MAGNIFICATION, AND

  Patient problems: Discomfort

  MAUDE report 14029168 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BILATERAL TULA TUBE PLACEMENT, TYMBION WAS WARMED UTILIZING THE TYMBION WARMER TO DESIRED TEMPERATURE PRIOR THE PATIENT'S ARRIVAL. DOCTOR INSPECTED THE PATIENT'S AUDITORY CANALS AND SIZED THE PATIENT TO A EP2B BILATERALLY BEFORE ASSEMBLING THE BILATERAL KIT. THE PATIENT'S AUDITORY CANALS WERE FILLED WITH TYMBION AND NO LEAKS WERE OBSERVED. TYMBION IONTOPHORESIS WAS INITIATED BILATERALLY AND THE PATIENT WAS COOPERATIVE AND AFFABLE THROUGHOUT THE THERAPY. NO DISCOMFORT WAS OBSERVED DURING TYMBION IONTOPHORESIS, WITH THE EXCEPTION OF THE PATIENT ATTEMPTING TO SCRATCH HIS BACK IN THE GENERAL AREA OF THE RETURN ELECTRODE. TYMBION IONTOPHORESIS CONCLUDED SUCCESSFULLY WITHOUT ANY ALERT LIGHTS. WITHIN 15 MINUTES OF THE CONCLUSION OF TYMBION IONTOPHORESIS, DOCTOR REMOVED THE EARSETS, AND AN UNIDENTIFIED BROWN-COLORED LIQUID WAS OBSERVED IN BOTH EARSETS RESERVOIRS. DOCTOR OBSERVED THE ANTERIOR-INFERIOR QUADRANT OF THE TYMPANIC MEMBRANE OF THE PATIENT'S LEFT EAR UNDER MAGNIFICATION, AND THEN ATTEMPTED TO TEST THE TYMPANIC MEMBRANE FOR ADEQUATE ANESTHESIA EMPLOYING A TM-TAP TECHNIQUE WITH THE RETRACTED TIP OF THE TUBE DELIVERY SYSTEM. THE PATIENT IMMEDIATELY DISPL

  Patient problems: Discomfort

  MAUDE report 14029164 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING TULA BMT PROCEDURE, THE IONTOPHORESIS PORTION OF THE PROCEDURE WAS SUCCESSFULLY COMPLETED IN NOMINAL MODE, HOWEVER, UPON TESTING THE RIGHT TYMPANIC MEMBRANE (TM) OF THE CHILD (RIGHT EAR DRUM) FOR ADEQUATE ANESTHETIZATION WITH TDS TIP (LEFT SIDE WAS NOT TESTED), IT WAS DETERMINED THAT THE TM WAS NOT ADEQUATELY ANESTHETIZED TO ATTEMPT THE TUBE DEPLOYMENT PORTION OF THE PROCEDURE AND ABORTED THE PROCEDURE. THE PROCEDURE WAS RESCHEDULED FOR OPERATING ROOM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13290272 ↗