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

Lot Number 04Z

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

No serious problem.Company recalls.Gum healthy gums.

• Brand Name: GUM BRAND PERIOSHIELD
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 11921912
• MDR Text Key: 254057409
• Report Number: MW5101657
• 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: 05/28/2021

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: 11/01/2022
• Device Lot Number: 04Z
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 61