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

Catalog Number 6964-X

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

Report received of a suction oral brush disengagement.Report stated patient bit down on the suction oral brush while brushing their teeth and the green foam disengaged with the green foam remaining in the patient's mouth.Reporter provided additional information stating the patient was in a "waking coma" state and had a tracheostomy when the patient bit down on the suction oral brush causing a piece of the foam to disengage inside the patient's mouth while oral care was being performed.The disengaged foam was removed by the healthcare provider with their fingers.No medical intervention was needed and the patient did not experience any adverse consequences.Although requested, no additional information was available.

Manufacturer Narrative

Involved device was discarded by facility and no photos were available of the involved device.Facility was able to provide the lot # for the involved device.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per product drawing.A labeling review of the finished good was performed.The instructions for use state ¿do not allow patient to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or cannot comprehend commands.Use caution with children and unresponsive individuals.Failure to follow these safety precautions may damage the device and present choking/aspiration hazard.¿ the suction oral brush was confirmed to be manufactured to specifications.The health professional using the suction oral brush did not follow the instructions on the outer bag label which cautioned the user to use a bite block and do not allow the patient to bite down on the suction oral brush.Involved device discarded by facility.

• Brand Name: INTL QCARE RX Q4 SYS W/CORINZ
• Type of Device: SUCTION ORAL TOOTHBRUSH
• 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: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 15381158
• MDR Text Key: 302836029
• Report Number: 0001419181-2022-00006
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2023
• Device Catalogue Number: 6964-X
• Device Lot Number: 85763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 70 KG