BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    SURGIWRAP® FROST

    MDR report key: 24126964 · Received January 20, 2026

    Report

    Report Number
    3004661493-2025-00001
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    January 24, 2023
    Report Date
    December 18, 2025
    Manufacturer
    MAST BIOSURGERY USA, INC
    Product Code
    FTL
    PMA / PMN Number
    K200918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT INVOLVED POST-OPERATIVE ILEUS REQUIRING HOSPITALIZATION FOLLOWING USE OF SURGIWRAP® FROST DURING COLORECTAL SURGERY. THE SUSPECT DEVICE WAS NOT RETURNED AND WAS THEREFORE NOT AVAILABLE FOR PHYSICAL EVALUATION. THE MANUFACTURER'S INVESTIGATION CONSISTED OF A REVIEW OF AVAILABLE CLINICAL INFORMATION AND COMPLAINT RECORDS. NO DEVICE MALFUNCTION, LABELING ISSUE, OR MANUFACTURING NONCONFORMANCE WAS IDENTIFIED. THE PHYSICIAN INDICATED THAT ALTERNATIVE CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT, AND A CAUSAL RELATIONSHIP TO THE DEVICE COULD NOT BE RULED OUT. NO REMEDIAL ACTION WAS INITIATED.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT ROBOTIC-ASSISTED ULTRA-LOW ANTERIOR RESECTION AND COLOSTOMY FOR RECTAL CANCER ON (B)(6) 2023, DURING WHICH SURGIWRAP FROST WAS APPLIED. POSTOPERATIVELY, THE PATIENT DEVELOPED ILEUS WITH SUBSEQUENT BOWEL OBSTRUCTION REQUIRING PROLONGED HOSPITALIZATION, IMAGING, NASOGASTRIC TUBE PLACEMENT, FASTING, FLUID INFUSION THERAPY, AND MEDICAL MANAGEMENT. THE PHYSICIAN-IN-CHARGE STATED THAT WHILE HARD STOOLS AT THE STOMA SITE WERE CONSIDERED THE MAIN CAUSE, A CAUSAL RELATIONSHIP WITH SURGIWRAP FROST COULD NOT BE COMPLETELY RULED OUT AS THE DEVICE MAY INHIBIT BOWEL MOVEMENT. THE PATIENT GRADUALLY IMPROVED WITH CONSERVATIVE TREATMENT AND NO PERMANENT IMPAIRMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174306 SURGIWRAP® FROST BIORESORBABLE ADHESION BARRIER FILM FTL MAST BIOSURGERY USA, INC 54967

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R NONE REPORTED.