MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCARE RX Q4 SYS W/CORINZ 20; SUCTION ORAL TOOTHBRUSH

Catalog Number	6964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation ongoing.
Event or Problem Description
Report received of a suction oral toothbrush foam disengagement.The reporter stated the green foam on the back of the suction oral toothbrush disengaged and was swallowed by the patient.Reporter stated this was the third time the green foam has come off the back of the suction oral toothbrush and a patient has swallowed it.A photograph was provided and product was returned for evaluation.Although several attempts were made to the reporter to obtain additional information, no response was received.
Event or Problem Description
Report received of a suction oral toothbrush foam disengagement.The reporter stated the green foam on the back of the suction oral toothbrush disengaged and was swallowed by the patient.Reporter stated this was the third time the green foam has come off the back of the suction oral toothbrush and a patient has swallowed it.A photograph was provided and product was returned for evaluation.Although several attempts were made to the reporter to obtain additional information, no response was received.
Additional Manufacturer Narrative
The involved device was returned from the facility for evaluation.Visual inspection of the device showed the top right corner of the foam missing.The missing piece of foam measured approximately 0.5 cm x 0.5 cm.Foam residue remained in place where the foam was missing indicating the presence of glue.During the manufacturing process, there are machine tests in place to ensure that the foam is adhered to the head of the suction oral brush.A labeling review was performed.The instructions for use state "use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.".The reporter did not state if a bite block was in use or if the patient bit down on the foam.A definitive root cause could not be determined.

• Brand Name: QCARE RX Q4 SYS W/CORINZ 20
• Common Device Name: SUCTION ORAL TOOTHBRUSH
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 12315976
• Report Number: 0001419181-2021-00014
• Device Sequence Number: 19795347
• Product Code: JOL
• UDI-Device Identifier: 50618029830758
• UDI-Public: 50618029830758
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: Other
• Device Catalogue Number: 6964
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1