Toothette Oral Care 6550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029800657), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2018Use of Device Problem; Use of Device Problem

  REPORT RECEIVED OF FOAM DISENGAGEMENT DUE TO USER ERROR. ON (B)(6) 2018, ORAL CARE WAS PERFORMED ON A MALE SEDATED AND VENTILATED PATIENT. THE REPORTER STATED DURING ORAL CARE THE PATIENT INVOLUNTARILY BIT DOWN ON THE SUCTION ORAL SWAB STICK AND THE GREEN FOAM DISENGAGED FROM THE STICK. THE REPORTER STATED THE FOAM WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S ORAL CAVITY AND NO INJURY OCCURRED TO THE PATIENT OR NURSE. THE REPORTER STATED THE INCIDENT OCCURRED DURING INITIAL USE OF THE PRODUCT AND A BITE BLOCK WAS NOT USED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571737 ↗