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

Lot Number 02A

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Nausea (1970); Sore Throat (2396)

Event Description

My daughter has been using gum perioshield and we just learned it was recalled.It may not be related, but it's important to note that since using this product she has complained of sore throat, queasiness and has had some issues with catching her breath.A couple of weeks ago we had her tested for covid and it came back negative.It may just be a cold or allergies, but who knows.Maybe it's the contamination in this product?.

• Brand Name: GUM PERIOSHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12016732
• MDR Text Key: 257402895
• Report Number: MW5101955
• 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: 06/15/2021

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: 09/01/2023
• Device Lot Number: 02A
• Was Device Available for Evaluation?: Yes
• 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 Age: 7 YR
• Patient Weight: 27