MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM PERIOSHEILD; RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)

Lot Number 2A

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2021

Event Description

This report is regarding the voluntary recall of gum perioshield mouth rinse.I received a notice from sunstar americas to check lot number of the product i purchased.I do have 2 bottles of product on the recall list.

• Brand Name: GUM PERIOSHEILD
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS INC.
• MDR Report Key: 12088018
• MDR Text Key: 259366680
• Report Number: MW5102200
• Device Sequence Number: 1
• Product Code: NTO
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/26/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 2A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 72