BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIWRAP FROST

    MDR report key: 24479827 · Received March 2, 2026

    Report

    Report Number
    3004661493-2026-00002
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    December 26, 2023
    Manufacturer
    MAST BIOSURGERY USA, INC.
    Product Code
    FTL
    PMA / PMN Number
    K200918
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THIS CASE WAS REPORTED FROM SINGLE BLIND, MULTICENTRE, RANDOMIZED CONTROLLED TRIAL. LOT NUMBER IS 54967, 54968.

    Description of Event or Problem · 0

    ON (B)(6) 2023: PHYSICIAN-IN-CHARGE OBTAINED CONSENT FROM THE PATIENT TO PARTICIPATE IN THIS CLINICAL TRIAL. ON (B)(6) 2023: LOW ANTERIOR RESECTION COMBINED WITH ROBOTIC-ASSISTED TRANSANAL TOTAL MESORECTAL EXCISION (TA-TME) AND TEMPORARY ILEOSTOMY FOR PRIMARY RECTAL CANCER WAS PERFORMED BY EMPLOYING (B)(6) [SURGIWRAP FROST]. ON (B)(6) 2023: THE PATIENT VISITED THE HOSPITAL AT THE FIRST TIME AFTER HE WAS DISCHARGED. ON (B)(6) 2023: THE PATIENT VISITED THE HOSPITAL, THEN COMPLAINED OF INTESTINAL GAS CESSATION AND ABDOMINAL DISTENTION. THE PHYSICIAN-IN-CHARGE DIAGNOSED ILEUS BASED ON CT FINDINGS, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT. AN NG TUBE WAS INSERTED; THE PHYSICIAN INSTRUCTED THE PATIENT TO KEEP FASTED. ALSO, THE PATIENT STARTED FLUIDS REPLACEMENT AND CEFMETAZOLE SODIUM INTRAVENOUSLY. ILEUS WAS NOT RECOVERED. ON (B)(6) 2023: AN ILEUS TUBE WAS INSERTED 185 CM AND SECURED. ON (B)(6) 2023: CONTINUOUS SUCTIONING WAS STARTED WITH A MERASACUUM (ELECTRIC LOW-PRESSURE SUCTION DEVICE) AND CEFMETAZOLE SODIUM INFUSION WAS DISCONTINUED. ON (B)(6) 2023: THE ILEUS TUBE WAS REMOVED, AND THE PATIENT RESUMED DRINKING. ON (B)(6) 2023: THE PATIENT RESUMED EATING. ON (B)(6) 2024: ABDOMINAL X-RAYS REVEALED IMPROVEMENT OF ILEUS, SO THE PATIENT COULD CONTINUE TO EAT. ILEUS WAS RECOVERING. ON (B)(6) 2024: ABDOMINAL X-RAYS SHOWED NO RELAPSE OF ILEUS AND THE PATIENT HAD GOOD DEFAECATION FROM THE STOMA. ALSO, THERE WAS NO COMPLAINT OF ABDOMINAL DISTENTION, SO THE PATIENT WAS DISCHARGED THE HOSPITAL. ILEUS WAS RECOVERED. PHYSICIAN'S COMMENTS: ALTHOUGH THIS EVENT MAY HAVE BEEN CAUSED BY INTESTINAL OBSTRUCTION DUE TO OVEREATING, THE POSSIBILITY OF ILEUS ADHESIVE CANNOT BE RULED OUT, AND WE CONSIDERED THAT A CAUSAL RELATIONSHIP BETWEEN (B)(6) [SURGIWRAP FROST] AND THIS EVENT MAY BE "POSSIBLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539374 SURGIWRAP FROST Mesh, surgical, polymeric FTL MAST BIOSURGERY USA, INC. 54967, 54968

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization BUTYRIC ACID BACTERIA| EDOXABAN TOSILATE HYDRATE| ROSUVASTATIN CALCIUM