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

Lot Number 05Z

Device Problem Product Quality Problem (1506)

Patient Problem Nausea (1970)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

I got nauseated within 15 minutes of using sunstar gum perioshield oral health rinse every time i used it.I did not swallow the product.I ordered it from (b)(6).

• Brand Name: GUM PERIOSHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12049973
• MDR Text Key: 258165747
• Report Number: MW5102039
• 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: 06/20/2021

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: No Information
• Device Expiration Date: 11/30/2022
• Device Lot Number: 05Z
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 74