MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC SOB W/PROX-MM-1PK 100; SUCTION ORAL BRUSH

Model Number	6572
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter discarded the involved product and did not provide photographs or lot information.Production history records could not be reviewed.The reporter confirmed that biting occurred, and a bite block was not in use.Per the packaging instructions it states, ¿use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.¿ the root cause could be attributed to user error related to biting.Due to the report of biting and review of labeling, there is insufficient evidence to conclude the reported issue was attributable to a quality defect or manufacturing operations.Discarded by reporter.
Event or Problem Description
Report received of foam disengagement due to user error.On (b)(6) 2019, oral care was performed on a male patient that who could not follow commands.The reporter stated during oral care the patient bit down on the suction oral brush head resulting in the foam disengaging from the back of the suction oral brush head.Reporter stated the patient refused to open his mouth for nursing staff to retrieve the disengaged foam.Reporter stated the patient chewed on the foam and swallowed the foam.Reporter stated no injury occurred to the patient or nursing staff.Reporter stated the incident occurred on initial use of the product and a bite block was not in use.Reporter stated it is unknown if foam remained on the back of the suction oral brush head.Reporter stated no photographs were available and the involved device was discarded.Reporter was unable to provide lot information for the involved device.Although requested, no additional information provided.

• Brand Name: TOC SOB W/PROX-MM-1PK 100
• Common Device Name: SUCTION ORAL BRUSH
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 8292477
• Report Number: 0001419181-2019-00001
• Device Sequence Number: 1203505
• Product Code: JOL
• UDI-Device Identifier: 50618029821169
• UDI-Public: 50618029821169
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 01/31/2019

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 Model Number: 6572
• Device Catalogue Number: 6572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1