Sage Self Oral Care 6302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029831194), received between Mar 11, 2021 and Mar 11, 2021 — 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.

• MalfunctionMar 11, 2021Material Separation; Material Separation

  REPORT RECEIVED OF A MALFUNCTION RESULTING IN A TOOTHBRUSH BRISTLE DISENGAGEMENT. ON (B)(6) 2021, AN INDEPENDENT PATIENT USED THE SAGE SELF ORAL CARE TOOTHBRUSH TO PERFORM ORAL HYGIENE. THE REPORTER STATED DURING USE OF THE PRODUCT A ¿COUPLE¿ BRISTLES CAME OFF IN THE PATIENT¿S MOUTH. REPORTER STATED THE PATIENT WAS ABLE TO SUCCESSFULLY REMOVE ALL DISENGAGED BRISTLES AND NO INJURY OCCURRED. THE DEVICE WAS DISCARDED AND NO PICTURES WERE PROVIDED. LOT INFORMATION WAS PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467736 ↗