BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET COOL DEVICE

    MDR report key: 22352617 · Received June 30, 2025

    Report

    Report Number
    MW5172083
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 19, 2025
    Manufacturer
    RECENSMEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A TARGET COOL DEVICE AND KIMERA EXOSOMES WERE SOLD TO ME AT THE (B)(6). THE EXOSOMES WERE PRESENTED AS ONLY AVAILABLE THROUGH BELLAVITA CLINICS, AND THE DEVICE WAS PROMOTED AS CLINICALLY COMPATIBLE. I WAS NOT PROVIDED TRAINING, DOCUMENTATION, OR ANY SAFETY INSTRUCTIONS. DURING A SCHEDULED TRAINING ZOOM CALL WITH BELLA VITA'S REPRESENTATIVE (B)(6) HAD SELF-ADMINISTERED THE EXOSOMES USING THE SAME GUN AND EXPERIENCED AN IMMEDIATE BURNING REACTION. (B)(6). I AM SUBMITTING THIS CONCERN DUE TO: POTENTIAL MISUSE OR UNSAFE COMBINATION OF DEVICE AND BIOLOGIC PRODUCT LACK OF CLINICAL GUIDANCE OR DOCUMENTED TRAINING MISREPRESENTATION OF DISTRIBUTOR STATUS I AM REPORTING THIS (B)(6) I AM SUBMITTING THIS REPORT NOT BECAUSE I PERSONALLY USED THE PRODUCT, BUT BECAUSE I AM NOW AFRAID TO USE IT (B)(6) THEY BOTH EXPERIENCED BURNING REACTIONS UPON SELF-ADMINISTRATION OF THE EXOSOMES USING THE BELLAVITA-SUPPLIED DEVICE. THIS HAS RAISED SERIOUS SAFETY CONCERNS (B)(6). I HAVE NOT USED THE PRODUCT (B)(6), AND I FEEL A DUTY TO REPORT IT TO PREVENT POTENTIAL HARM TO OTHERS. (B)(6) EXPERIENCED WHAT THEY DESCRIBED AS NEAR-ANAPHYLACTIC REACTIONS AFTER APPLYING THE KIMERA EXOSOMES USING THE BELLAVITA-SUPPLIED DEVICE. (B)(6). I HAVE NOT USED THE PRODUCT SINCE, OUT OF FEAR FOR PATIENT SAFETY. THIS IS THE PRIMARY REASON FOR MY REPORT -- I CANNOT ETHICALLY PROCEED WITHOUT CLARIFICATION FROM THE FDA AND MANUFACTURER. I WANT TO CLARIFY THAT I HAVE NOT USED OR EVEN UNPACKED THE TARGET COOL DEVICE OR THE EXOSOMES. (B)(6) I FROZE. I COULDN'T BRING MYSELF TO PROCEED. (B)(6). I'M FILING THIS REPORT BECAUSE I BELIEVE IT'S CRITICAL THAT THE FDA BE MADE AWARE. MY GREATEST FEAR IS HARMING PATIENTS, AND I COULD NEVER MOVE FORWARD WITH A PRODUCT THAT MAY POSE DANGER, (B)(6). I HAVE NOT USED THIS PRODUCT ON ANY PATIENT BECAUSE I AM DEEPLY CONCERNED AFTER HEARING WHAT HAPPENED (B)(6). I'M FILING THIS REPORT OUT OF CAUTION AND ETHICAL DUTY. I WOULD NEVER WANT TO CAUSE HARM - AND I HOPE THIS HELPS PREVENT OTHERS FROM BEING PUT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234822 TARGET COOL DEVICE UNIT, CRYOSURGICAL, ACCESSORIES GEH RECENSMEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female