BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIOSHIELD ORAL RINSE

    MDR report key: 12849362 · Received November 19, 2021

    Report

    Report Number
    0001413787-2021-00013
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    April 26, 2021
    Report Date
    July 27, 2021
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    NTO
    PMA / PMN Number
    K053166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    I ORDERED THIS GUM PERIOSHILED AS PART OF A CHRISTMAS GIFT FOR MY MOM. SHE USED THE MOUTHWASH AND THEN START TO COMPLAIN ABOUT NOT HAVING ENOUGH OXYGEN. WE THOUGHT HER O2 MACHINE WAS MALFUNCTIONING AND REPLACED IT. THE PROBLEM CONTINUED. SHE WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF ACUTE HYPOXEMIC RESPIRATORY FAILURE, DYSPNEA, COUGH, CHEST TIGHTNESS. O2 SAT LEVEL OF 83% ON ROOM AIR. DRY COUGH IN TRIAGE 95% ON 3L. SHE WAS DISCHARGED. SHE HAD COPD PRIOR TO THIS AND IS VULNERABLE TO CHEST/BREATHING RELATED ILLNESS. ABOUT 30 TESTS WERE PERFORMED DURING HER STAY. I DON'T KNOW WHICH ONES TO HIGHLIGHT. NOW FEEL THIS MOUTHWASH CONTRIBUTED TO THE PROBLEM. HOSPITALIZED FOR 8 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739095 PERIOSHIELD ORAL RINSE ORAL RINSE NTO SUNSTAR AMERICAS, INC. 1775R

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female Hospitalization AMLODIPINE| BUDESONIDE-FORMOTEROL| CALCIUM SUPPLEMENT| CARVEDILOL| FAMOTIDINE| IPRATROPIUM| ISOSORBIDE MONONITRATE| PREDNISONE| SPIRIVA HANDIHALER