BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERAPH 100

    MDR report key: 21955785 · Received May 2, 2025

    Report

    Report Number
    3014015528-2025-00018
    Event Type
    Death
    Date Received
    May 2, 2025
    Date of Event
    April 7, 2024
    Report Date
    May 2, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN (B)(6) WHERE THE CLAIMED ADVERSE EVENT 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

    PER THE REPORTER, THE PATIENT STARTED "BEING FILTERED" IN (B)(6) 2024 IN (B)(6). WHEN SHE ARRIVED IN (B)(6) SHE WAS "VERY SICK" AND NEEDED TO BE STABILIZED AND MONITORED OVERNIGHT IN THE (B)(6) CLINIC PRIOR TO TREATING. THE PATIENT DIED (B)(6) 2024. THE DEVICE WAS BEING USED OUTSIDE OF THE UNITED STATES IN (B)(6). THE PATIENT WAS BEING TREATED BY DR. (B)(6) AND DR. (B)(6). EXTHERA HAS REACHED OUT TO BOTH OF THESE PHYSICIANS AS WELL AS THE FACILITY IN (B)(6). THE FACILITY HAS STATED IT WAS NOT AWARE OF ANY ADVERSE EVENTS. THE PHYSICIANS HAVE NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831491 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death