MAUDE Adverse Event Report: SUNSTAR AMERICAS INC. GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES; RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)

Device Problem Nonstandard Device (1420)

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

Event Date 06/01/2021

Event Description

I received a letter in the mail dated (b)(6) 2021 regarding sunstar americas inc (sai), gum perioshield oral health rinse.I was not able to find that recall letter in your inventory but did find that another product from sunstar with the same microorganism (burkholderia cepacia or contaminants) was previously recalled, so i am submitting my response form here.I purchased a total of 10 bottles of the product in question, with 6 remaining unused and one partially used.The product is in a blue bottle.

• Brand Name: GUM(R) PERIOSHIELD ORAL HEALTH RINSE 300 ML (10 FL. OZ.) BLUE BOTTLES
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS INC.
• MDR Report Key: 12016740
• MDR Text Key: 257425635
• Report Number: MW5101956
• Device Sequence Number: 9
• 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: 06/09/2021
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 65