QCARE RX Q4 SYS W/CORINZ 20

Description of Event or Problem

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.