MAUDE Adverse Event Report: SAGE PRODUCTS LLC SAGE SELF ORAL CARE 4PK 12; SUCTION ORAL TOOTHBRUSH

Catalog Number	6304
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of a bristle disengagement.Report stated a nurse was using the suction oral brush during a demonstration led by a sales representative when three bristles disengaged inside her mouth.The nurse was able to easily remove the bristles from her mouth.The nurse did not experience any adverse consequences.The lot number was provided for evaluation; however, the involved device was discarded by the facility.Although requested, no additional information was available.
Additional Manufacturer Narrative
Involved device was discarded by facility and no photos were available of the 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 for the quality checks performed at sage products.The suction oral brush is manufactured at a third party manufacturer, team technologies, who is currently completing an investigation of this report.Involved device discarded by facility.
Additional Manufacturer Narrative
Reporter did not provide involved device or photographs of the device, therefore a visual inspection could not be completed.A product history review was completed with all checks showing a passing result.The third party supplier of the involved device was contacted for additional investigation.Their investigation showed that all sampling plans were met and deemed acceptable.
Event or Problem Description
Report received of a bristle disengagement.Report stated a nurse was using the suction oral brush during a demonstration led by a sales representative when three bristles disengaged inside her mouth.The nurse was able to easily remove the bristles from her mouth.The nurse did not experience any adverse consequences.The lot number was provided for evaluation; however, the involved device was discarded by the facility.Although requested, no additional information was available.

• Brand Name: SAGE SELF ORAL CARE 4PK 12
• Common Device Name: 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: 15456427
• Report Number: 0001419181-2022-00007
• Device Sequence Number: 6863755
• Product Code: JOL
• UDI-Device Identifier: 50618029831205
• UDI-Public: 50618029831205
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/02/2022

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 Expiration Date: 12/04/2023
• Device Catalogue Number: 6304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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 Sex: Female