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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.