BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERAPH 100

    MDR report key: 21440489 · Received February 22, 2025

    Report

    Report Number
    3014015528-2025-00015
    Event Type
    Death
    Date Received
    February 22, 2025
    Date of Event
    March 13, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 P5 (FEMALE, 42, DIAGNOSED WITH METASTATIC BREAST CANCER PRIOR TO BEING TREATED WITH SERAPH 100) FELT CHEST PAIN AND LEARNED OF A LARGE NEW TUMOR BETWEEN HER RIBS AND LUNGS AFTER SECOND TREATMENT. SHE DIED THREE MONTHS AFTER TREATMENT, APPROXIMATELY IN JUNE 2024. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619913 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Death