BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIOSHIELD ORAL RINSE

    MDR report key: 12849386 · Received November 19, 2021

    Report

    Report Number
    0001413787-2021-00014
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    January 4, 2021
    Report Date
    September 16, 2021
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    NTO
    PMA / PMN Number
    K053166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739096 PERIOSHIELD ORAL RINSE ORAL RINSE NTO SUNSTAR AMERICAS, INC. 1775R 02A, 01A, AND 02Z

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| O