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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Notified by (b)(6) that i had purchased mouthwash contaminated with burkholderia cepacia.I don't know if i am suffering adverse effects.I did have a cut in my gum and it has been irritated while using this product.Gum - 1775r perioshield oral health rinse, 10 ounce bottle gum has informed us that the product may be contaminated with micro-organisms burkholderia cepacia.I received a notice to file a report.

• Brand Name: GUM PERIOSHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICA'S INC.
• MDR Report Key: 12040574
• MDR Text Key: 257750326
• Report Number: MW5102010
• 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

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR