BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIYA SYSTEM

    MDR report key: 19003897 · Received March 28, 2024

    Report

    Report Number
    MW5153364
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 23, 2023
    Report Date
    March 26, 2024
    Manufacturer
    GALVANIZE THERAPEUTICS
    Product Code
    OAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS IN REGARDS TO QUESTIONABLE BUSINESS PRACTICES WITH REGARD TO THE GALVANIZE/ALIYA SYSTEM. THEY ARE MARKETING THIS PRODUCT AS EFFECTIVE FOR TREATMENT OF PULMONARY NODULES. WE TRIED IT IN 5 PATIENTS AND IT DID NOT WORK AT ALL. THIS IS EXCEEDINGLY DANGEROUS AS IT IS PULMONARY ABLATION OF LUNG NODULES IS A HIGH RISK PROCEDURE. WE ARE PUBLISHING OUR EXPERIENCE NOW. HOWEVER, THIS MAY NOT BE ENOUGH TO GET THE WORD OUT. I AM GETTING WORD THAT THEY ARE AGGRESSIVELY SELLING THIS PRODUCT TO THE IR COMMUNITY. I THINK THIS COMPANY IS TOO FOCUSED ON PROFITS AND NOT THE OUTCOMES OF CANCER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589164 ALIYA SYSTEM LOW ENERGY DIRECT CURRENT THERMAL ABLATION SYSTEM OAB GALVANIZE THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other