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

Lot Number 05Z

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Numbness (2415); Taste Disorder (4422)

Event Date 06/01/2021

Event Type  Injury  

Event Description

I used the mouthwash perioshield by gumbrand, lot 05z (which is now being recalled).After rinsing, my entire mouth went numb and i lost taste for 2 hours.Recall notice: reason for recall: sai is voluntarily recalling gum perioshield oral health rinse products manufactured between august 2018 through february 2021.The recalled products may be contaminated with micro-organisms burkholderia cepacia and/or burkholderia contaminants.

• Brand Name: PERIO SHIELD ORAL HEALTH RINSE
• Type of Device: RINSE, ORAL, ANTIBACTERIAL (BY PHYSICAL MEANS)
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.
• MDR Report Key: 12016685
• MDR Text Key: 257431878
• Report Number: MW5101951
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/02/2022
• Device Lot Number: 05Z
• 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: 27 YR
• Patient Weight: 75