MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCARE RX Q4 SYS W/CORINZ 20; Covered Yankauer

Catalog Number	6964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 06/18/2026 search of the fda manufacturer and user facility device experience (maude) identified a report (mw5159828) of yankauer soft tip disengagement.During oral care, the patient bit down on the device, resulting in the soft tip disengaging from the yankauer.The detached soft tip was subsequently removed from the patient's mouth.Additional information was requested; however, no further details were provided.The device was not available for evaluation as it was discarded.

• Brand Name: QCARE RX Q4 SYS W/CORINZ 20
• Common Device Name: Covered Yankauer
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): Sage Products LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: anansar ituen ; 3909 three oaks road; cary, IL 60013 ; +1(815)455-4700
• MDR Report Key: 25787247
• Report Number: 0001419181-2026-00018
• Device Sequence Number: 9608227
• Product Code: JOL
• UDI-Device Identifier: 50618029830758
• UDI-Public: 50618029830758
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 160 LB
• Patient Race: Black Or African American