BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERAPH 100

    MDR report key: 21440668 · Received February 22, 2025

    Report

    Report Number
    3014015528-2025-00014
    Event Type
    Death
    Date Received
    February 22, 2025
    Date of Event
    April 13, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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, JANUARY 23, 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, JANUARY 23, 2025. PATIENT P4 (MALE, DIAGNOSED WITH METASTATIC ABDOMINAL CANCER PRIOR TO TREATMENT WITH SERAPH 100) "HEALTH DECLINED PRECIPITOUSLY" AFTER RECEIVING FILTER TREATMENT IN (B)(6) 2024. EXACT DATE OF P4'S TREATMENT UNKNOWN BUT OCCURRED APPROXIMATELY TWO MONTHS BEFORE HIS DEATH ON (B)(6) 2024. 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). FURTHER INVESTIGATION REVEALED THAT P4 RECEIVED 3 FILTERS IN (B)(6) AROUND LATE (B)(6) 2024 AS OFF-LABEL TREATMENT FOR A LIPOSARCOMA MASS. SEVERAL WEEKS OUT HIS CT SCAN SHOWED 2CM GROWTH OF PELVIC MASS. BETWEEN (B)(6) AND (B)(6), THE TUMOR HAD GROWN BY ~50%. AT THAT TIME P4 WAS DIAGNOSED WITH TUMOR LYSIS SYNDROME (URIC ACID LEVEL INCREASED AMONG OTHER THINGS. IMPLIED TREATMENT TO REDUCE LEVELS OF POTASSIUM AND CALCIUM AS WELL). PER P4'S FATHER ON (B)(6) 2024, "LAST NIGHT [P4]'S HEART WAS ALSO ACTING UP WITH REALLY HIGH BRATS TO COMPENSATE FOR THE REALLY LOW BLOOD PRESSURE. 60/42 AT [ONE] POINT... HE HAD TO GO ON OXYGEN AS WELL LAST NIGHT - AND THEN THAT CHANGED BLOOD PRESSURE AND HEART RATE." P4 ALSO "HAD PAIN IN HIS LEFT LEG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044589 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death