BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURASTAT

    MDR report key: 22814265 · Received August 15, 2025

    Report

    Report Number
    22814265
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 12, 2025
    Manufacturer
    3-D MATRIX EUROPE
    Product Code
    QAU
    UDI-DI
    04560436590354
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: PATIENT WAS AN ACTIVE BLEED DURING THE PROCEDURE RECEIVING BLOOD TRANSFUSION. MULTIPLE TYPES OF INTERVENTION WERE DONE AND THE PURA STAT WAS DELAYING CARE. A SECOND SYRINGE OF PURA STAT WAS USED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300959 PURASTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU 3-D MATRIX EUROPE 621-035 23B23A30 04560436590354

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male