BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE® ADVANCED SURGICAL SOLUTION

    MDR report key: 22840037 · Received August 19, 2025

    Report

    Report Number
    3021784063-2025-00001
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ROCHAL TECHNOLOGIES LLC
    Product Code
    FRO
    PMA / PMN Number
    K223377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION COULD NOT BE COMPLETED BECAUSE THE FACILITY DOES NOT RETAIN THE REQUIRED PRODUCT INFORMATION AND ATTEMPTS TO OBTAIN IT FROM EXTERNAL SOURCES WERE UNSUCCESSFUL. BASED ON THE NUMBER OF UNITS DISTRIBUTED TO DATE AND THE REPORTED INCIDENTS, THE ESTIMATED POTENTIAL INCIDENT RATE IS 0.02%. SURVEILLANCE ACTIVITIES WILL CONTINUE TO ASSESS ANY EMERGING TRENDS OR ADDITIONAL REPORTING.

    Description of Event or Problem · 0

    CASE (B)(4) (B)(6) 2025: 87-YEAR-OLD MALE WITH CECAL OBSTRUCTION. OPEN HEMI-COLECTOMY WAS PERFORMED. NO UNUSUAL PROCEDURE COMPLICATIONS WERE NOTED. AT THE COMPLETION OF THE CASE AND PRIOR TO CLOSURE BIASURGE® WAS USED. BIASURGE WAS INSTILLED USING GRAVITY FLOW WITHOUT PULSE LAVAGE. IT WAS DELIVERED TO THE PERITONEAL CAVITY BY GRAVITY LAVAGE, DWELL TIME WAS ONE TO TWO MINUTES, AND THE FLUID WAS THEN SUCTIONED OUT OF THE CAVITY PRIOR TO CLOSURE. THE SURGEON STATED THAT THE FLUID WAS NOT WARMED PRIOR TO INSTILLATION. ANESTHESIA NOTED SIGNIFICANT HYPOTENSION WITHIN MINUTES WITH A BLOOD PRESSURE DROP TO 40/20. FLUID BOLUSES AND VASOPRESSORS WERE USED. PATIENT STABILIZED AND SENT TO RECOVERY ROOM. HE HAD ELEVATED TROPONIN CARDIAC ENZYMES POST-OPERATIVELY AND REMAINS HOSPITALIZED AS OF (B)(6) 2025. THE SURGEON INITIALLY ATTRIBUTED THIS SCENARIO TO THE PATIENT'S AGE AND HEALTH STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252553 BIASURGE® ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO ROCHAL TECHNOLOGIES LLC BAS-0101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention| H| L