BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE ADVANCED SURGICAL SOLUTION

    MDR report key: 22569270 · Received July 22, 2025

    Report

    Report Number
    MW5173071
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ROCHAL TECHNOLOGIES LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEVERE REFRACTORY HYPOTENSION AND VASOPLEGIA OCCURRED IMMEDIATELY AFTER THE SURGEON IRRIGATED THE PERITONEAL CAVITY WITH BIASURGE IRRIGATION SOLUTION AT THE END OF A BOWEL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937803 BIASURGE ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO ROCHAL TECHNOLOGIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening