BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE ADVANCED SURGICAL SOLUTION

    MDR report key: 21559815 · Received March 10, 2025

    Report

    Report Number
    MW5167440
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 5, 2025
    Manufacturer
    SANARA MEDTECH / ROCHAL TECHNOLOGIES LLC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEVERE HYPOTENSION AND VASOPLEGIA AFTER INITIATION OF INTRA-OPERATIVE IRRIGATION OF THE ABDOMINAL CAVITY WITH BIASURGE ADVANCED SURGICAL IRRIGATION. BLOOD PRESSURE DROPPED TO 60/30 IMMEDIATELY AFTER INITIATION AND DURING IRRIGATION OF BIASURGE SOLUTION INTO THE ABDOMINAL CAVITY INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339619 BIASURGE ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO SANARA MEDTECH / ROCHAL TECHNOLOGIES LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other| L