BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE ADVANCED SURGICAL SOLUTION

    MDR report key: 21559757 · Received March 10, 2025

    Report

    Report Number
    MW5167439
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 5, 2025
    Manufacturer
    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

    HYPOTENSION AND SEVERE VASOPLEGIA SEVERELY AFTER IRRIGATION OF THORACIC CAVITY WITH BIASURGE ADVANCED SURGICAL SOLUTION (SANARA MEDTECH). BP DROPPED TO 70S/50S IMMEDIATELY AFTER INITIATION OF IRRIGATION WITH BIASURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339618 BIASURGE ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO ROCHAL TECHNOLOGIES LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male Other| L