BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE® ADVANCED SURGICAL SOLUTION

    MDR report key: 22840036 · Received August 19, 2025

    Report

    Report Number
    3021784063-2025-00004
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 16, 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 #4: (B)(6) 2025: THE SURGEON OPERATED ON A 79-YEAR-OLD WITH A PERFORATED APPENDIX. A LAPAROSCOPIC APPENDECTOMY WAS PERFORMED. BIASURGE® WAS USED AT THE END OF THE PROCEDURE. BIASURGE WAS INSTILLED USING THE APPROPRIATE LAPAROSCOPIC PORTAL. WITHIN FIVE MINUTES, HYPOTENSION WAS NOTED WHICH REQUIRED FLUID BOLUS AND VASOPRESSORS. PATIENT DEVELOPED MARKEDLY ELEVATED LIVER ENZYMES AND WAS HOSPITALIZED FOR SEVERAL DAYS FOR OBSERVATION. NO PERMANENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252552 BIASURGE® ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO ROCHAL TECHNOLOGIES LLC BAS-0101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Life Threatening| R| H