MAUDE Adverse Event Report: SAGE PRODUCTS LLC IND CARE KIT W/ CORINZ 50; MANUAL TOOTHBRUSH

Model Number 6004

Device Problem Material Separation (1562)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The involved device was not returned, photographs were not provided, and the lot number was not identified.Therefore, a visual/functional inspection could not be performed.The complainant alleged several bristles became disengaged from the ultra-soft toothbrush from the #6004 independent care system with corinz oral rinse, into her mouth when she was brushing her teeth.The ultra-soft toothbrush is currently manufactured by a third-party supplier.The supplier was notified of this report.A conclusive investigation cannot be conducted without lot information, photographs of the defect or the actual defective sample.A quality or manufacturing issue cannot be confirmed.Device involved in incident discarded.

Event Description

Report received of an ultra-soft toothbrush bristle disengagement that occurred on (b)(6) 2024.Reporter stated several bristles became disengaged from the ultra-soft toothbrush, contained in product #6004 independent care system with corinz oral rinse, into her mouth when she was brushing her teeth.Reporter stated she was able to spit the disengaged bristles out independently and did not experience any adverse consequences.The toothbrush was discarded.Lot information is not available.No photos are available.Although requested, no other information was available.

• Brand Name: IND CARE KIT W/ CORINZ 50
• Type of Device: MANUAL 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: 18937235
• MDR Text Key: 338749131
• Report Number: 0001419181-2024-00003
• Device Sequence Number: 1
• Product Code: EFW
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6004
• Device Catalogue Number: 6004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female