Q-Care 6904Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029830081), received between Aug 8, 2019 and Aug 8, 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. 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.

• MalfunctionAug 8, 2019Material Separation; Material Separation

  REPORT RECEIVED OF A MALFUNCTION RESULTING IN A SUCTION ORAL SWAB FOAM DISENGAGEMENT. ON (B)(6) 2019, ORAL CARE WAS PERFORMED ON A PATIENT. THE REPORTER STATED PART OF THE GREEN FOAM DISENGAGED WHILE IN THE PATIENT'S MOUTH. REPORTER STATED THE DISENGAGED FOAM WAS SUCCESSFULLY RETRIEVED AND NO INJURY OCCURRED. REPORTER STATED PATIENT WAS ORALLY INTUBATED AND SEDATED, HOWEVER, THE REPORTER DID NOT KNOW IF BITING OCCURRED. REPORTER STATED MOST OF THE GREEN FOAM REMAINED ADHERED TO THE SUCTION STRAW. THE DEVICE WAS DISCARDED AND NO PICTURES WERE AVAILABLE. LOT INFORMATION WAS NOT PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875932 ↗