BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEP8 CPAP CLEANER

    MDR report key: 15043021 · Received July 15, 2022

    Report

    Report Number
    MW5110909
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    July 12, 2022
    Report Date
    July 13, 2022
    Manufacturer
    SLEEP8, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING MY CPAP MASK AFTER USING A SLEEP8 CLEANING DEVICE. I WOKE UP SEVERAL HOURS LATER WITH EXTREME BURNING IN MY NOSTRILS AND SINUSES, AND A STRONG METALLIC TYPE ODOR. I HAD TO TAKE THE MASK OFF AND GO OUTSIDE TO GET FRESH AIR. IT TOOK AN HOUR OR SO FOR THE BURNING SENSATION TO SUBSIDE. A DAY LATER, MY SINUSES ARE STILL IRRITATED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251293 SLEEP8 CPAP CLEANER DISINFECTANT, MEDICAL DEVICES LRJ SLEEP8, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male FAMOTIDINE | GARLIC| MAGNESIUM| PAPAYA ENZYME| RESMED CPAP MACHINE