BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERAPH 100

    MDR report key: 21441956 · Received February 23, 2025

    Report

    Report Number
    3014015528-2025-00002
    Event Type
    Injury
    Date Received
    February 23, 2025
    Date of Event
    March 6, 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 (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 P1 HAD DIFFICULTY BREATHING AFTER TREATMENT. AFTER GOING TO THE EMERGENCY ROOM, HE WAS DIAGNOSED WITH PLEURAL EFFUSION. PATIENT P1 REQUIRED SURGICAL INTERVENTION TO DRAIN HIS LUNGS OF "A LITER OF REDDISH-BROWN LIQUID". DAY OF INCIDENT UNKNOWN BUT DESCRIBED AS "SOON AFTER THE HE RETURNED TO HOME", ASSUMED TO BE SOMETIME AFTER (B)(6) AND BEFORE RETURNING TO (B)(6) 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693402 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other