Brasseler USA 5028425U0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887919884699), received between Nov 28, 2023 and Apr 28, 2025 — classified as 2 injuries.

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

• InjuryApr 28, 2025Device Handling Problem; Device Handling Problem

  ON 3/31/2025, INTER-MED, INC. WAS MADE AWARE OF AN INCIDENT THAT OCCURRED ON (B)(6) 2025 IN WHICH THE SYRINGE DETACHED FROM THE TRITON BOTTLE WHILE THE SYRINGE WAS BEING FILLED, RESULTING IN TRITON SOLUTION SPRAYING INTO THE EMPLOYEE'S RIGHT EYE AND EAR, AS WELL AS ONTO THE EMPLOYEE'S FOREHEAD, CHEEK, NECK, AND CHEST. EMERGENCY EYEWASH WAS PERFORMED, AND THE EMPLOYEE WENT TO THE ER FOR ADDITIONAL TREATMENT AND TESTING, INCLUDING EYE WASHES AND PH TESTING.

  Patient problems: Insufficient Information

  MAUDE report 21921097 ↗
• InjuryNov 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WENT TO THE DOCTOR DUE TO PAIN ON (B)(6) 2023. THE DOCTOR REPORTED IRREVERSIBLE PULPITIS/ EARLY NECROSIS WITH SAP AND PERFORMED AN EMERGENCY PULPECTOMY ON TOOTH 45 (ADA 29). A 30 GA VENTED IRRIGATION NEEDLE MOUNTED ON 5CC LUER LOCK SYRINGE WAS USED. ALSO, A RUBBER DAM ISOLATION AND HIGH VOL SUCTION WITH NARROW BORE AND LARGE BORE EVACUATION TIPS WERE USED. NOTHING NOTABLE OCCURRED DURING THE PROCEDURE. THE DOCTOR SAID THEY FOLLOWED THE INSTRUCTIONS FOR USE; HOWEVER, THE INSTRUCTIONS SAY KEEP REFRIGERATED BUT THE DOCTOR SAID THEY MAY NOT HAVE BEEN AS DILIGENT TO KEEP THE PRODUCT THERE WHEN NEEDING IT HANDY FOR PROCEDURES SO THEY STORE IT IN A CLIMATE-CONTROLLED CUPBORD AWAY FROM LIGHT WHERE SIMILAR MATERIALS ARE STORED. NO AIR BUBBLES WERE NOTICED. THE CAP WAS PLACED ON WITH THE ARROWS THE CORRECT WAY. THE PAIN DID NOT GO AWAY AND THE PATIENT REPORTED SWELLING IN THE LOWER RIGHT JAW REGION THE SAME EVENING. THE DOCTOR PRESCRIBED AMOXYCILLIN 500MG TID FOR 7 DAYS AND THEN AZITHROMYCIN 500MG OD FOR 5 DAYS. THE PATIENT'S PAIN LEVEL STARTED TO REDUCE ON (B)(6) 2023 BUT THERE WAS STILL A HARD INDURATED SWELLING IN THE VESTIBULE.

  Patient problems: Pain

  MAUDE report 18221936 ↗