MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC PLS BCRB-20PK 1000; SINGLE USE ORAL SWAB

Catalog Number 6076

Device Problem Material Separation (1562)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The affected 6076 product was not returned, photographs were not provided, and the lot number was not identified.Therefore, a product history review nor product inspection could be performed.However, a swab head pull test is performed on each of the swabs, testing the swab attachment strength and any swab that fails will be rejected.The root cause of the reported complaint could not be determined as the product was not returned, photographs were not provided, and the lot was not provided.However, the swab foam has the ability to be ripped on sharp materials as the foam is not very dense.

Event Description

It was reported that pieces of foam from a sage toothette oral swab with sodium bicarbonate became separated from the swab during use.Reporter stated she has braces and was using the device to clean her mouth.Reporter stated pieces of the swab ripped, separating from the swab and got stuck in her braces.The reporter stated the pieces were removed when she rinsed her mouth after use.No adverse consequences were reported.Several attempts were made to gather additional information.Reporter did not respond to these attempts.Although requested, no additional information was available.

• Brand Name: TOC PLS BCRB-20PK 1000
• Type of Device: SINGLE USE 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: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 17876532
• MDR Text Key: 324986647
• Report Number: 0001419181-2023-00006
• Device Sequence Number: 1
• Product Code: KXF
• 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: 10/05/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6076
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Home
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• 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
• Patient Sex: Female