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

Lot Number 02A

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Description

Perioshield recall.We have 3 bottles.Two from lot 02a, one from lot 01a.Recommended by dentist.

• Brand Name: PERIOSHIELD
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12384764
• MDR Text Key: 268984148
• Report Number: MW5103561
• Device Sequence Number: 2
• 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: 08/25/2021
• 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: 02A
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1