BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERAPH 100

    MDR report key: 22023631 · Received May 15, 2025

    Report

    Report Number
    3014015528-2025-00005
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 10, 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, (B)(6) 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(B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. AS REPORTED IN NYT ARTICLE, PATIENT P1 (IDENTIFIED AS MALE, 55, DIAGNOSED WITH LATE-STAGE METASTATIC ESOPHAGEAL CANCER) HAD A SECOND INSTANCE OF PLEURAL EFFUSION AFTER TREATMENT AND REQUIRED SURGICAL INTERVENTION TO DRAIN FLUID FROM HIS LUNGS. INCIDENT ESTIMATED TO OCCUR DURING HIS STAY AT THE MAYO CLINIC'S FLORIDA CAMPUS SOMETIME BETWEEN ARRIVAL ON (B)(6) AND DEPARTURE ON (B)(6) 2024. THE ARTICLE STATES THAT TREATMENTS WITH SERAPH 100 TOOK PLACE OUTSIDE THE UNITED STATES, IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393407 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention