BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASYRA GALVANIC SKIN RESPONSE MEASUREMENT

    MDR report key: 11669910 · Received April 14, 2021

    Report

    Report Number
    MW5100796
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 27, 2021
    Report Date
    April 12, 2021
    Manufacturer
    UNK
    Product Code
    GZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DR (B)(6) OF (B)(6) CLINIC: ALTERNATIVES FOR HEALTH AND WELLNESS IN (B)(6) USED A MACHINE ASYRA APPROVED TO MEASURE SKIN GALVANIZATION TO "MAKE PERSONALIZED HOMEOPATHY REMEDIES DESIGNED JUST FOR YOU AND YOUR ISSUES." SHE USED THIS FOR MY SISTER AS PART OF HER TREATMENT FOR STAGE 4 LUNG CANCER AND GAVE HER THE IMPRESSION THE TUMOR WAS SHRINKING AND SHE WAS GETTING BETTER. SHE ENDED UP IN THE HOSPITAL A WEEK LATER WITH LUNGS FULL OF FLUID AND IN PALLIATIVE CARE. I WAS NOT THERE AT THE TIME. MY SISTER TOLD US ABOUT IT. SINCE IT IS DIFFICULT TO TRAVEL TO (B)(6) DUE TO COVID, I CANNOT INDEPENDENTLY CONFIRM HOW THE MACHINE WAS USED. I THINK SOMEONE SHOULD INVESTIGATE WHETHER OR NOT IT'S BEING USED IN ACCORDANCE WITH MACHINE GUIDELINES. I HAVE SEEN NUMEROUS OTHER COMPLAINTS ABOUT MISUSE OF ASYRA IN A WEB SEARCH. HERE IS ONE: (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560052 ASYRA GALVANIC SKIN RESPONSE MEASUREMENT DEVICE, GALVANIC SKIN RESPONSE MEASUREMENT GZO UNK DON'T KNOW DON'T KNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization