MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL TOC SOB-1PK 100; SUCTION ORAL BRUSH

Catalog Number 6577-X

Device Problem Material Separation (1562)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

Report received of suction oral brush foam disengagements.Reporter stated the foam on the suction oral brush ¿releases easily and with risk of release inside the patient¿s mouth, [users] are removing the foam before brushing¿.Reporter stated this event has occurred several times with multiple patients, however; no patient specific details were available.Reporter stated no bite block was in use during oral care on patients.Reporter stated the patients did not bite down on the suction oral brush stick and only a piece of the foam became disengaged.Reporter stated they were unsure if the facility had been reusing the i suction oral brush, however; the facility was educated in regard to the suction oral brush being single use only as well as training on the use of the suction oral brush.Patients experienced no serious outcomes or delays in treatment.Involved devices and lot number were not available.Although requested, no additional information was available.

Manufacturer Narrative

Samples were not available for evaluation and the reporter was not able to provide the involved lot number.Product history records could not be reviewed due to the lot number not being available.A labeling review of the finished good was performed.The packaging label includes the following instructions, "do not allow patient to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or those who cannot comprehend commands.Use caution with children and unresponsive individuals.Failure to follow these safety precautions may damage the device and present a chocking/aspiration hazard.May not function as intended/potential risk of cross-contamination if device is reused.".The root cause of the reported complaint could not be determined.

• Brand Name: INTL TOC SOB-1PK 100
• Type of Device: SUCTION ORAL BRUSH
• 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: 14492480
• MDR Text Key: 292611939
• Report Number: 0001419181-2022-00002
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6577-X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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