MAUDE Adverse Event Report: SUNSTAR AMERICAS, INC. PERIOSHIELD ORAL RINSE

Model Number 1775R

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

Patient Problems Rash (2033); Skin Infection (4544)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Customer stated he used product with his face mask and it infected his skin around his mouth he started to get soars.He had been using the product for about a year as a recommendation form his dentist.So started use around (b)(6) 2020.And noticed he started getting soars around the outside of his mouth in (b)(6) 2021.He then went to his doctor for medical attention.Doctor gave him a steroid cream medication for the infection as he could not find out why he was getting soars around the outside of his mouth.He did not tell the doctor he was using our periosheild.Then he went back to the doctor in (b)(6) 2021 as the soars were not going away.Doctor then gave him a different steroid cream to use.Soars still did not go away.He then got the recall letter about perioshield on (b)(6) 2021 and went back to doctor.Doctor then told him to discontinue the use of the perioshield right away.The soars then started to go away after a week of not using the perioshield.

Event Description

Customer stated he used product with his face mask and it infected his skin around his mouth he started to get sores.He had been using the product for about a year as a recommendation form his dentist.So started use around (b)(6) 2020.And noticed he started getting sores around the outside of his mouth in (b)(6) 2021.He then went to his doctor for medical attention.Doctor gave him a steroid cream medication for the infection as he could not find out why he was getting sores around the outside of his mouth.He did not tell the doctor he was using our periosheild.Then he went back to the doctor in (b)(6) 2021 as the sores were not going away.Doctor then gave him a different steroid cream to use.Sores still did not go away.He then got the recall letter about perioshield on (b)(6) 2021 and went back to doctor.Doctor then told him to discontinue the use of the perioshield right away.The sores then started to go away after a week of not using the perioshield.

• Brand Name: PERIOSHIELD ORAL RINSE
• Type of Device: ORAL RINSE
• Manufacturer (Section D): SUNSTAR AMERICAS, INC.; 301 east central road; schaumburg IL 60195
• Manufacturer (Section G): SUNSTAR AMERICAS, INC.; 301 e. central road; schaumburg IL 60195
• Manufacturer Contact: deanna anderson ; 301 east central road; schaumburg, IL 60195
• MDR Report Key: 12849386
• MDR Text Key: 285676695
• Report Number: 0001413787-2021-00014
• Device Sequence Number: 1
• Product Code: NTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/16/2021

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: Lay User/Patient
• Device Model Number: 1775R
• Device Lot Number: 02A, 01A, AND 02Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic