Q-Care 6962Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029830760), received between May 10, 2021 and May 10, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 10, 2021Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION ORAL SWAB DISENGAGEMENT. THE REPORTER STATED THE PATIENT BIT DOWN ON THE SUCTION ORAL SWAB CAUSING THE GREEN FOAM TO DISENGAGE INSIDE THE PATIENT¿S MOUTH. THE REPORTER STATED THAT SHE WAS UNAWARE IF THE PATIENT WAS ALERT AND ORIENTED. THE REPORTED ISSUE OCCURRED DURING THE INITIAL USE OF DEVICE AND NO BITE BLOCK WAS IN USE. REPORTER STATED THE DISENGAGED FOAM WAS SUCCESSFULLY RETRIEVED WITHOUT DIFFICULTY AND NO INJURY OCCURRED. THE INVOLVED DEVICE WAS RETURNED FOR EVALUATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800988 ↗