BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIASURGE® ADVANCED SURGICAL SOLUTION

    MDR report key: 22840039 · Received August 19, 2025

    Report

    Report Number
    3021784063-2025-00002
    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 #2: (B)(6) 2025: 36-YEAR-OLD HEALTHY MALE WITH A PERFORATED APPENDIX. A LAPAROSCOPIC APPENDECTOMY WAS PERFORMED. BIASURGE® WAS INSTILLED USING THE APPROPRIATE LAPAROSCOPIC PORTAL. WITHIN MINUTES, THE PATIENT DEVELOPED TACHYCARDIA WITH HYPOTENSION TO 70/40. FLUID BOLUS AND VASOPRESSORS WERE USED FOR RESUSCITATION. POST-OPERATIVELY THE PATIENT DEVELOPED AN ACUTE KIDNEY INJURY WITH A DOUBLING OF HIS CREATININE. THIS STABILIZED AND RETURNED TO BASELINE. THE OPERATIVE SURGEON AND ANESTHESIA DISCUSSED THIS CASE AND HAD AN INITIAL IMPRESSION THAT THIS MOST LIKELY WAS RELATED TO THE EARLY SEPSIS NATURE OF THE PERFORATED APPENDIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252555 BIASURGE® ADVANCED SURGICAL SOLUTION DRESSING, WOUND, DRUG FRO ROCHAL TECHNOLOGIES LLC BAS-0101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Hospitalization| R| L