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

Lot Number "02A,02A,01A,02Z"

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Skin Disorders (4543)

Event Date 01/01/2021

Event Type  Injury  

Event Description

The (b)(4) - gum - 1775r perioshield oral health rinse, 10 ounce bottle used this contaminated product in conjunction with a face mask and caused infections on the skin.Reported to the manufacturer - referred to manufacturer 6/28/2021 said would respond, no response.

• Brand Name: GUM PERIO SHIELD
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS INC.
• MDR Report Key: 12377136
• MDR Text Key: 270302719
• Report Number: MW5103524
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/01/2023
• Device Lot Number: "02A,02A,01A,02Z"
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 77