BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERAPH 100

    MDR report key: 21441869 · Received February 22, 2025

    Report

    Report Number
    3014015528-2025-00017
    Event Type
    Death
    Date Received
    February 22, 2025
    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. PATIENT P7, NOT OTHERWISE IDENTIFIED, DIED FOLLOWING TREATMENT. OVERALL THE ARTICLE INDICATES THAT P6 WAS ONE OF SEVERAL PATIENTS SEEKING OFF-LABEL TREATMENT FOR CANCER. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA. FURTHER INVESTIGATION INDICATES THAT TREATMENT AND ANY SUBSEQUENT ADVERSE EVENT WOULD HAVE OCCURRED SOME TIME IN 2024, DUE TO THE TIMING OF THE ARTICLE AND THE AVAILABILITY OF TREATMENT IN ANTIGUA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693372 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death