BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE® ADVANCED SURGICAL SOLUTION

    MDR report key: 22840038 · Received August 19, 2025

    Report

    Report Number
    3021784063-2025-00003
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 25, 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 (B)(4). SURVEILLANCE ACTIVITIES WILL CONTINUE TO ASSESS ANY EMERGING TRENDS OR ADDITIONAL REPORTING.

    Description of Event or Problem · 0

    CASE #3: (B)(6) 2025: 61-YEAR-OLD FEMALE WITH COLONIC OBSTRUCTION AND INTUSSUSCEPTION. OPEN COLECTOMY PERFORMED. PATIENT WAS HEALTHY AND WITHOUT SEPSIS. ANESTHESIA AND THE OPERATIVE SURGEON PREPARED FOR THE USE OF BIASURGE® PRIOR TO CLOSURE. BIASURGE WAS INSTILLED USING GRAVITY FLOW WITHOUT PULSE LAVAGE. THE FLUID WAS REMOVED AFTER ONE TO TWO MINUTES. A HYPOTENSIVE REACTION REQUIRING FLUIDS AND VASOPRESSORS. POST-OPERATIVELY THE PATIENT DEVELOPED ELEVATED LIVER ENZYMES WHICH STABILIZED AND THEN RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252554 BIASURGE® ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO ROCHAL TECHNOLOGIES LLC BAS-0101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H| L