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

Lot Number 01Z

Device Problem Microbial Contamination of Device (2303)

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

Event Date 06/15/2021

Event Description

Gum - 1775r perioshield oral health rinse, 10 ounce bottle gum has informed us that the product may be contaminated with micro-organisms burkholderia cepacia.

• Brand Name: PERIOSHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12088092
• MDR Text Key: 259277191
• Report Number: MW5102201
• 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

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?: No
• Device Operator: No Information
• Device Expiration Date: 04/01/2022
• Device Lot Number: 01Z
• 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: 61 YR
• Patient Weight: 57