MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL TOC SOB-SOS-SWAB-UNTR 100; SUCTION TOOTHBRUSH

Model Number 6576-X

Device Problem Material Separation (1562)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Report received of a suction toothbrush foam disengagement.Received one package of the 6576-x from brazil distributor in which the foam on the suction toothbrush was not attached to the device.The affected package was sealed, and the foam was retained in the package.The lot number was provided.No additional information was provided.

Manufacturer Narrative

The affected 6576-x was inspected, and lot information was provided.Upon inspection, it was confirmed that the entirety of the foam on the suction toothbrush was not attached to the device.Additionally, there was adhesive glue residue on the suction toothbrush head, indicating the accurate presence of glue.However, there was no foam stuck to the glue on the suction toothbrush head.There are multiple controls in place to ensure the foam is securely attached to the suction toothbrush head.If any suction toothbrushes do not meet the specification of each of these steps, it will be rejected.Additionally, form fill lines are a manual process where the operators pick and place each component into the finished good blister pack.All quality checks passed inspection and the product met all release requirements.The root cause of the detached foam cannot be confirmed.

• Brand Name: INTL TOC SOB-SOS-SWAB-UNTR 100
• Type of Device: SUCTION 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: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 18265146
• MDR Text Key: 329679201
• Report Number: 0001419181-2023-00008
• Device Sequence Number: 1
• Product Code: JOL
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6576-X
• Device Catalogue Number: 6576-X
• Device Lot Number: 88510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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