BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    PURAGEL/PURASINUS

    MDR report key: 15657709 · Received October 24, 2022

    Report

    Report Number
    3015528146-2022-00002
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    August 16, 2022
    Report Date
    October 23, 2022
    Manufacturer
    3-D MATRIX
    Product Code
    NHB
    PMA / PMN Number
    K183015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT (PURAGEL/PURASINUS) USED ON A MIDDLE TURBINATE RESECTION AND THE PATIENT HAD ROUGH TIME WAKING UP FROM ANESTHESIA AND STARTED "BUCKING"(FAIRLY COMMON) AND THE PATIENT STARTED BLEEDING HEAVILY. BLEEDING COULDN'T BE CONTROLLED, PATIENT WAS MOVED BACK TO OR AND PUT BACK TO SLEEP AND A NASOPORE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495420 PURAGEL/PURASINUS PURAGEL NHB 3-D MATRIX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Prefer Not To Disclose Hospitalization