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

Lot Number 02A

Device Problems Contamination (1120); Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Headache (1880); Discomfort (2330); Numbness (2415); Sensitivity of Teeth (2427); Increased Sensitivity (4538)

Event Date 06/07/2021

Event Type  Injury  

Event Description

This mouthwash has caused extreme sensitivity to my gums and teeth.I am unable to drink or eat hot or cold items without discomfort.I have also experienced periodic shortness of breath and headaches.Additionally, this product caused severe mouth numbness lasting for 2 days each time.I received a recall notice stating the product has been contaminated with burkholderia cepacia and/or burkholderia contaminants from the manufacturer.

• Brand Name: GUM PERIO SHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC
• MDR Report Key: 12032115
• MDR Text Key: 257433450
• Report Number: MW5101968
• 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: 06/16/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 78