Toothette Oral Care 6513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029800640), received between Mar 8, 2021 and Mar 8, 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 8, 2021Material Separation; Material Separation

  REPORT RECEIVED OF A SWAB DISENGAGEMENT WHILE USING SAGE TOOTHETTE ORAL CARE SUCTION SWAB DEVICE. REPORTER STATED ON (B)(6) 2021 A NURSE WAS PERFORMING ORAL CARE ON AN INTUBATED AND SEDATED PATIENT WHEN THE PLASTIC STRAW OF THE SUCTION SWAB BROKE INTO TWO PIECES. THE NURSE WAS ABLE TO REMOVE THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC FROM THE PATIENTS MOUTH WITHOUT INCIDENT. ALTHOUGH, THE REPORTER STATED THE PATIENT DID NOT BITE DOWN ON THE STRAW OF THE SUCTION SWAB; A BITE BLOCK WAS NOT IN USE DURING ORAL CARE. LOT INFORMATION AND A PHOTOGRAPH WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440028 ↗