BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEP8 OZONE SANITIZING DISINFECTANT

    MDR report key: 17975224 · Received October 19, 2023

    Report

    Report Number
    MW5147159
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    January 1, 2021
    Report Date
    October 19, 2023
    Manufacturer
    SLEEP8 INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING BECAUSE SHE IS HAVING PROBLEMS WITH CHRONIC COUGH, SHORTNESS OF BREATH, "LUNG IRRITATION", AND CHEST PAIN EVER SINCE SHE BEGAN USING "SLEEP8 OZONE DISINFECTANT" IN COMBINATION WITH HER RESMED DEVICE. REPORTER STATES HER SYMPTOMS BEGAN ON APPROXIMATELY (B)(6) 2021, AND THAT SHE HAS BEEN GOING TO THE DOCTOR "CHRONICALLY" FOR THE PAST COUPLE OF YEARS DUE TO HER SYMPTOMS. SHE STATES SHE HAS BEEN ON STEROID MEDICATIONS, COUGH MEDICATIONS, HAS HAD CHEST X-RAYS, AND BEEN EVALUATED BY A CARDIOLOGIST DUE TO HER ONGOING HEALTH PROBLEMS. REPORTER STATES SHE FEARS SHE HAS SUFFERED PERMANENT DAMAGE AND THAT SHE IS SCHEDULED FOR ANOTHER "WELLNESS CHECK" AT HER DOCTOR'S OFFICE "NEXT WEEK". REPORTER STATES SLEEP8 IS THE ONLY CLEANER SHE HAS EVER USED WITH HER RESMED. REPORTER ALSO STATES SHE DISCOVERED OTHER REPORTS ABOUT SLEEP8 WITH CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) DEVICE USE ON "MAUDE" FROM 2019, AND THAT THIS ALARMED AND UPSET HER. REPORTER STATES SHE IS UPSET THAT "SLEEP8 KNEW ABOUT PROBLEMS AS FAR BACK AS 2019" YET CONTINUED TO SELL THEIR PRODUCT FOR USE. REPORTER STATES SHE HAS CALLED "FDA ALLEGATIONS" BUT WAS ONLY ABLE TO LEAVE A MESSAGE AND HAS NOT RECEIVED A CALL BACK. REPORTER ALSO STATES SHE WILL BE CONTACTING SLEEP8 WITH THE INTENTION OF TALKING TO SOMEONE IN "THEIR LEGAL DEPARTMENT". REFERENCE REPORT: MW5147160.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996119 SLEEP8 OZONE SANITIZING DISINFECTANT DISINFECTANT, MEDICAL DEVICES LRJ SLEEP8 INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other "COUGH MEDICATIONS"| "STEROID MEDICATIONS"| RESMED AIRCURVE 10 VAUTO