Sage Self Oral Care 6304Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029831200), received between Sep 20, 2022 and Sep 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionSep 20, 2022Material Separation; Material Separation

  REPORT RECEIVED OF A BRISTLE DISENGAGEMENT. REPORT STATED A NURSE WAS USING THE SUCTION ORAL BRUSH DURING A DEMONSTRATION LED BY A SALES REPRESENTATIVE WHEN THREE BRISTLES DISENGAGED INSIDE HER MOUTH. THE NURSE WAS ABLE TO EASILY REMOVE THE BRISTLES FROM HER MOUTH. THE NURSE DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE LOT NUMBER WAS PROVIDED FOR EVALUATION; HOWEVER, THE INVOLVED DEVICE WAS DISCARDED BY THE FACILITY. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456427 ↗