BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOCLEAN II

    MDR report key: 11825009 · Received May 13, 2021

    Report

    Report Number
    MW5101354
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 11, 2021
    Manufacturer
    SOCLEAN, INC.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    BLOOD PRESSURE SOARED; WE PURCHASED A SOCLEAN II TO CLEAN HUSBAND'S CPAP MACHINE. AFTER USING ONLY ONCE, PLUS A TEST RUN, HE SUFFERED TOXIC OZONE EXPOSURE. HE FELT WOOZY; HE IS A HEART PATIENT ALSO ON BLOOD PRESSURE MEDICATION. I TOOK HIS BLOOD PRESSURE. IT WAS 188/118! WE TOOK HIS BLOOD PRESSURE EVERY 5 MINUTES FOR 45 MINUTES. IT WENT DOWN A LITTLE BUT WAS STILL IN THE 170S/100-110S. WE CALLED HIS PRIMARY PHYSICIAN WHO SAW HIM IMMEDIATELY. HE LISTENED TO THE HEART, DID AN EKG, TOOK BLOOD PRESSURE. HE TOLD US THAT OZONE CAN DEFINITELY RAISE BLOOD PRESSURE. THE ONLY CONTRAINDICATIONS LIST FOR THIS PRODUCT IS IN THE MANUAL INSIDE THE BOX WHICH YOU ONLY SEE AFTER PURCHASE. THE DOCTOR TOLD US TO STOP USING AND IMMEDIATELY RETURN IT, WHICH WE DID. NOW I READ ON THE FDA WEBSITE THAT THIS MACHINE IS NOT APPROVED FOR USE IN THE US. ALSO, CONTINUED USE OF BOTH THE OZONE CLEANERS AND EVEN THE ULTRAVIOLET CLEANERS CAN DAMAGE THE MACHINE, TO SAY NOTHING OF THE DAMAGE TO THE PATIENT'S HEALTH. AFTER WE RETURNED FROM THE DOCTOR, EVEN AFTER OPENING WINDOWS AND RUNNING FANS, I COULDN'T BELIEVE HOW SATURATED THE AIR WAS IN THE BEDROOM WHERE BOTH THE CPAP AND SOCLEAN II WERE LOCATED. THERE SHOULD BE SOME SORT OF BLACK BOX WARNING OR, BETTER YET, A VERY PUBLIC WARNING AS TO JUST HOW DANGEROUS THIS PRODUCT IS. A PERSON WITH A DIMINISHED SENSE OF SMELL COULD EVEN SUCCUMB TO THE OZONE WITH CONTINUED USE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717418 SOCLEAN II DISINFECTANT, MEDICAL DEVICES LRJ SOCLEAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other