BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERAPH 100

    MDR report key: 22023627 · Received May 15, 2025

    Report

    Report Number
    3014015528-2025-00006
    Event Type
    Death
    Date Received
    May 15, 2025
    Date of Event
    April 18, 2024
    Report Date
    February 21, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS STATED IN THE NYT, SEE CARREYROU, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, JANUARY 23, 2025. THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN ANTIGUA WHERE THE CLAIMED ADVERSE EVENTS TOOK PLACE AND WITH THE TREATING PHYSICIAN. THE FACILITY HAS STATED THAT IT WAS NOT AWARE OF ANY ADVERSE EVENTS. THE PHYSICIAN HAS NOT RESPONDED.

    Description of Event or Problem · 0

    THIS INFORMATION WAS REPORTED PUBLICLY BY THE NEW YORK TIMES. SEE CARREYROU, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, JANUARY 23, 2025. AS REPORTED IN NYT ARTICLE, PATIENT P1 (IDENTIFIED AS MALE, 55, DIAGNOSED WITH LATE-STAGE METASTATIC ESOPHAGEAL CANCER) SAW PROGRESSION OF HIS CANCER AFTER TREATMENT. PER THE ARTICLE, "TUMORS IN HIS LIVER, ADRENAL GLANDS, BONES, AND SOFT TISSUES HAD MULTIPLIED AND GROWN." HIS WIFE CLAIMED THAT THE TREATMENT ACCELERATED MR. HUDLOW'S CANCER PROGRESSION. DAY OF INCIDENT UNKNOWN BUT ASSUMED TO BE BETWEEN THE DAY HE ARRIVED AT THE MAYO CLINIC AND THE DAY THE HE LEFT TO GO HOME (APRIL 10TH TO APRIL 16TH 2024). HE DIED ON APRIL 18TH 2024, APPROXIMATELY 1-2 WEEKS AFTER HIS LAST TREATMENT. THE ARTICLE STATES THAT SERAPH 100 TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393403 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death