BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN 2

    MDR report key: 12008122 · Received June 15, 2021

    Report

    Report Number
    MW5101912
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    June 6, 2021
    Report Date
    June 13, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED THE SOCLEAN 2 CPAP CLEANING MACHINE. THE FIRST NIGHT I IMMEDIATELY FELT A HEADACHE (I SUFFER FROM MIGRAINE). THE HEADACHE WOULD LAST THE MAJORITY OF THE NEXT DAY AND RETURN EACH NIGHT. NIGHT FIVE, I HAD NO HEADACHE WHEN PUTTING ON MY CPAP MASK WHICH WAS TAKEN RIGHT OUT OF THE SOCLEAN 2 MACHINE (CLEANED IT 14 HOURS PRIOR AND LET IT SIT IN THE CLOSED MACHINE TO ALLOW THE OZONE TO DISSIPATE) AND IMMEDIATELY GOT A HEADACHE ONCE I STARTED BREATHING THE AIR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894058 SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability