Toothette Oral Care 6572Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029821164), received between Jan 31, 2019 and Jan 31, 2019 — 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.

• MalfunctionJan 31, 2019Material Separation; Material Separation

  REPORT RECEIVED OF FOAM DISENGAGEMENT DUE TO USER ERROR. ON (B)(6) 2019, ORAL CARE WAS PERFORMED ON A MALE PATIENT THAT WHO COULD NOT FOLLOW COMMANDS. THE REPORTER STATED DURING ORAL CARE THE PATIENT BIT DOWN ON THE SUCTION ORAL BRUSH HEAD RESULTING IN THE FOAM DISENGAGING FROM THE BACK OF THE SUCTION ORAL BRUSH HEAD. REPORTER STATED THE PATIENT REFUSED TO OPEN HIS MOUTH FOR NURSING STAFF TO RETRIEVE THE DISENGAGED FOAM. REPORTER STATED THE PATIENT CHEWED ON THE FOAM AND SWALLOWED THE FOAM. REPORTER STATED NO INJURY OCCURRED TO THE PATIENT OR NURSING STAFF. REPORTER STATED THE INCIDENT OCCURRED ON INITIAL USE OF THE PRODUCT AND A BITE BLOCK WAS NOT IN USE. REPORTER STATED IT IS UNKNOWN IF FOAM REMAINED ON THE BACK OF THE SUCTION ORAL BRUSH HEAD. REPORTER STATED NO PHOTOGRAPHS WERE AVAILABLE AND THE INVOLVED DEVICE WAS DISCARDED. REPORTER WAS UNABLE TO PROVIDE LOT INFORMATION FOR THE INVOLVED DEVICE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292477 ↗