BRASSELER USA 5026059U2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810988030391), received between Dec 2, 2022 and Dec 26, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 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.

• InjuryDec 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DOCTOR WAS USING THE HANDPIECE WHEN THE BUR CAME OFF IN THE PATIENT'S MOUTH AND WAS SWALLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048946 ↗
• InjuryDec 2, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  DOCTOR WAS USING THE HANDPIECE WHEN THE BUR CAME OFF IN THE PATIENT'S MOUTH AND WAS SWALLOWED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15905713 ↗