MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC SOS W/PROX 100; SUCTION ORAL SWAB

Catalog Number	6512
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per the product drawing.A labeling review of the finished good was performed.The packaging label includes the following instructions, "use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use.If not, remove any particles from oral cavity." the root cause of the reported complaint could not be determined.Product not available.
Event or Problem Description
Report received of a suction oral swab disengagement.Reporter stated a suction oral swab disengaged inside the patient's mouth.Reporter did not respond to four attempts made to obtain additional information.Involved device was not available for return but lot number was provided.

• Brand Name: TOC SOS W/PROX 100
• Common Device Name: SUCTION ORAL SWAB
• 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: 14853809
• Report Number: 0001419181-2022-00004
• Device Sequence Number: 4909498
• Product Code: JOL
• UDI-Device Identifier: 50618029800638
• UDI-Public: 50618029800638
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: Lay User/Patient
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 6512
• Device Lot Number: 86628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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: Unknown