TULA EP2BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840128600085), received between Aug 9, 2022 and Aug 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, DURING TULA PROCEDURE, THE PATIENT WAS FITTED WITH SIZE 2 EARPLUG IN ONE EAR, THE EAR WAS FILLED APPROPRIATELY, AND THE CONTROL UNIT DISPLAYED AN ALERT WHEN THE HCP ATTEMPTED TO INITIATE IONTOPHORESIS. IT WAS DETERMINED THAT THE HCP HAD ATTEMPTED TO START THE CHANNEL THAT WAS NOT YET CONNECTED; WHEN THEY PRESSED THE CORRECT CHANNEL, IONTOPHORESIS INITIATED APPROPRIATELY. THE SURGEON THEN ATTEMPTED TO PLACE THE SECOND EARSET USING A SIZE 2 EARPLUG, DETERMINED THAT IT WAS TOO SMALL AND CHANGED TO A SIZE 3 EARPLUG. THEN, THE EAR WAS FILLED AND IONTOPHORESIS INITIATED. DURING IONTOPHORESIS, THE PATIENT WAS MOVING SIGNIFICANTLY; BOTH THE PARENTS AND MULTIPLE HCPS ATTEMPTED TO RESTRAIN THE PATIENT MOVEMENT. THE EARSETS WERE DISLODGED MULTIPLE TIMES LEADING TO ALERTS ON THE CONTROL UNIT. THE ALERTS MAY ALSO HAVE BEEN DUE TO LEAKS. THE PATIENT WAS NOT ABLE TO BE DISTRACTED WITH BEHAVIOR MANAGEMENT TECHNIQUES. THE CASE WAS ABORTED. AFTER THE PATIENT LEFT, THE NP STATED THAT THEY JUST COULDN'T GET THE EARSETS/EARPLUGS TO STAY IN. LATER THAT EVENING, THE SURGEON COMMUNICATED THAT HE HAD INVESTIGATED THE EARSETS AFTER THE PROCEDURE. HE STATED HIS OPINION THAT THE EARSET V

  Patient problems: Insufficient Information

  MAUDE report 15195699 ↗