Q-Care 6804Recalls & reported problems
Sage Products, LLC · Q-Care, Q4, Oral Cleansing & Suctioning System · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618029841216), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Material Separation
REPORT RECEIVED OF A COVERED YANKAUER SOFT OVERMOLDED TIP DISENGAGEMENT DUE TO BITING. REPORTEDLY, A 42-YEAR-OLD MALE PATIENT WITH A HISTORY OF CEREBRAL PALSY WAS ADMITTED TO THE MEDICAL-SURG UNIT AT THE FACILITY ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF (RESPIRATORY SYNCYTIAL VIRUS) RSV. ON (B)(6) 2026, A FAMILY MEMBER AT BEDSIDE USED THE COVERED YANKAUER TO ATTEMPT TO SUCTION THE PATIENT'S MOUTH. A BITE BLOCK WAS NOT IN USE. THE PATIENT BIT DOWN ON THE YANKAUER TUBE, BEHIND THE TIP. THE PATIENT'S FAMILY MEMBER ATTEMPTED TO PULL THE YANKAUER OUT OF THE PATIENT'S MOUTH. EVENTUALLY, THE PATIENT DID OPEN THEIR MOUTH AND THE YANKAUER WAS REMOVED. THE PATIENT THEN BEGAN TO EXPERIENCE, INCREASED HEART RATE, BLOOD PRESSURE AND COUGHING. STAFF THEN NOTICED THAT THE TIP WAS NO LONGER ATTACHED TO THE YANKAUER AND DETERMINED THAT THE PATIENT HAD ASPIRATED THE TIP. THE PATIENT WAS TRANSFERRED TO THE ICU, SEDATED AND ADMINISTERED A PARALYTIC. HE WAS INTUBATED AND A BRONCHOSCOPY WAS PERFORMED. THE DISENGAGED TIP OF THE DEVICE WAS LOCATED IN THE PATIENT'S RIGHT MAINSTEM BRONCHUS AND REMOVED. THE PATIENT RECOVERED FROM SEDATION AND WAS EXTUBATED WITHOUT ISSUE. THE PATIENT DID NOT EXPERIEN
Patient problems: Airway Obstruction
MAUDE report 24778654 ↗
Other APPLICATOR, ABSORBENT TIPPED, NON-STERILE devices
- AVANOS* 12251Avanos Medical, Inc. · APPLICATOR, ABSORBENT TIPPED, NON-STERILE1 report
- AVANOS* 122548Avanos Medical, Inc. · APPLICATOR, ABSORBENT TIPPED, NON-STERILE1 report
- Q-Care 6962Sage Products, LLC · APPLICATOR, ABSORBENT TIPPED, NON-STERILE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.