BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERAPH 100

    MDR report key: 22023625 · Received May 15, 2025

    Report

    Report Number
    3014015528-2025-00012
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 11, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS STATED IN THE NYT, SEE (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN (B)(6) 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 (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. PATIENT P3 (MALE, 47, DIAGNOSED WITH METASTATIC RECTAL AND LIVER CANCER) WAS DESCRIBED AS "WHITE AS A SHEET" SHORTLY AFTER TREATMENT AND AFTER STANDING AND WALKING "SLUMPED TO THE FLOOR UNCONSCIOUS AND BEGAN SHAKING". PER THE ARTICLE, A PHYSICIAN INITIALLY CLAIMED THAT PATIENT P3 WAS EXPERIENCING HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), BUT LAB TESTS LATER INDICATED THAT HIT WAS "NOT THE CULPRIT," AND THE PATIENT'S WIFE BELIEVES HE SUFFERED BLOOD LOSS DUE TOO FREQUENT CHANGES OF CLOGGED FILTERS. PATIENT P3 RECEIVED A BLOOD TRANSFUSION AND WAS ADMITTED TO THE ICU TO RECOVER. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN (B)(6). THE DEVICE WAS BEING USED OFF-LABEL FOR THE TREATMENT OF CANCER, OUTSIDE OF THE UNITED STATES IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392439 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Hospitalization| L| R