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

Catalog Number 6512

Device Problem Material Separation (1562)

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

Event Date 06/13/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 302522630
• Report Number: 0001419181-2022-00004
• Device Sequence Number: 1
• Product Code: JOL
• UDI-Device Identifier: 50618029800638
• UDI-Public: 50618029800638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 6512
• Device Lot Number: 86628
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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