BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEP 8 CPAP CLEANING COMPANION

    MDR report key: 11010510 · Received December 11, 2020

    Report

    Report Number
    MW5098342
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 21, 2020
    Report Date
    December 9, 2020
    Manufacturer
    SLEEP 8, INC.
    Product Code
    LRJ
    UDI-DI
    6022400263
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CPAP CLEANING MACHINE. SLEEP 8. FACE MASK (NOSE MASK) HAD WEIRD SMELL AND BURNING SENSATION. HEADACHE THE FOLLOWING DAY, FATIGUE, BLOATING, WEIGHT GAIN. HAVE NOTICED THIS OCCURS AFTER CLEANING ONCE/WEEK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459376 SLEEP 8 CPAP CLEANING COMPANION DISINFECTANT, MEDICAL DEVICES LRJ SLEEP 8, INC. SLP82043 6022400263

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other ESTRADIOL| LEXAPRO| PROGESTERONE