BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAST SURGIWRAP FROST BIORESORBABLE SHEET

    MDR report key: 24476747 · Received February 27, 2026

    Report

    Report Number
    3004661493-2026-00001
    Event Type
    Death
    Date Received
    February 27, 2026
    Date of Event
    August 14, 2023
    Report Date
    October 26, 2023
    Manufacturer
    MAST BIOSURGERY USA, INC.
    Product Code
    FTL
    PMA / PMN Number
    200918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALE PATIENT HAD STAGE 3 PRIMARY RECTAL CANCER. HE HAD NEOADJUVANT CHEMOTHERAPY AND NEOADJUVANT RADIOTHERAPY PRIOR TO STARTING THE TRIAL (BETWEEN (B)(6) 2023). ON (B)(6) 2023, HE UNDERWENT ROBOT-ASSISTED LAPOROSCOPIC ULTRA-LOW ANTERIOR RESECTION AND D3 DISSECTION (LOO). AT THE SAME TIME, A TEMPORARY STOMA WAS CREATED. THE PHYSICIAN-IN-CHARGE CONFIRMED THE CLINICAL TRIAL EXCLUSION CRITERIA AND DETERMINED THAT THE PATIENT WAS ELIGIBLE. THE PHYSICIAN USED SURGIWRAP FROST FOR THE SURGERY. THE ELAPSED TIME BETWEEN THE SURGERY AND THE ESTIMATED TIME OF THE PATIENT'S DEATH WAS APPROXIMATELY 4 WEEKS. NO AUTOPSY WAS PERFORMED AND THEREFORE, NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE USE OF THE SURGIWRAP FROST SHEET COULD BE FOUND. THE PHYSICIAN-IN-CHARGE INDICATED THAT THERE WERE NO OBVIOUS SIGNS OF ABDOMINAL DISTENSION, NO FINDINGS OF SUSPECTED INTRA-ABDOMINAL HEMORRHAGE AND NO OBVIOUS VOMITING. HENCE, THERE IS NO EVIDENCE TO SUPPORT THAT THE MEDICAL DEVICE, SURGIWRAP FROST BIORESORBABLE SHEET, WAS THE CAUSE OF THE DEATH. PLEASE NOTE: THE FOLLOWING CLINICAL CODE AND MEDICAL DEVICE CODE WERE USED ONLY TO FACILITATE COMPLETION OF THE MOR FORM BUT THEY DO NOT TRULY APPLY SINCE THE CAUSE OF THE DEATH IS UNKNOWN. THE TRUE CLINICAL SITUATION COULD NOT BE DETERMINED BECAUSE THE PATIENT DIED WHEN HE WAS ALONE IN HIS HOME, SO THERE IS NO EVIDENCE TO CONFIRM THAT HE HAD ABDOMINAL PAIN. ADDITIONALLY, SINCE NO AUTOPSY WAS PERFORMED, THERE WAS NO EVIDENCE TO SUPPORT THAT THE MEDICAL DEVICE MALFUNCTIONED. SECTION H. 1. HEALTH EFFECT - CLINICAL DATA: FDA CODE: 1685 -ABDOMINAL PAIN. 2. MEDICAL DEVICE PROBLEM CODE: FDA CODE: 1631 - UNEXPECTED THERAPEUTIC RESULTS.

    Description of Event or Problem · 0

    THE PATIENT WAS A 76-YEAR-OLD MAN WHO WAS PARTICIPATING IN A CLINICAL TRIAL IN JAPAN. ON (B)(6) 2023, THE PATIENT UNDERWENT ROBOTIC-ASSISTED LAPARASCOPIC SURGERY WITH ULTRA-LOW ANTERIOR RESECTION. AT THAT TIME, THE SURGIWRAP FROST PRODUCT (MEDICAL DEVICE) BIORESORBABLE SHEET/FILM (MEDIUM SIZE) WAS APPLIED TO THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ABOUT 3 WEEKS LATER ON (B)(6) 2023. TWO WEEKS LATER AFTER DISCHARGE, ON (B)(6) 2023, THE PATIENT MISSED HIS APPOINTMENT AT THE HOSPITAL FOR AN OUTPATIENT VISIT. THE FAMILY WERE CONTACTED. THEY TRIED TO CONTACT THE PATIENT WHO WAS LOCKED IN HIS HOME. THE POLICE WERE CONTACTED AND INTERVENED. THEY FOUND THE PATIENT DEAD IN HIS HOME (THIS WAS APPROXIMATELY 5 WEEKS AFTER THE SURGERY). THE POLICE INDICATED THAT THE CAUSE OF DEATH WAS UNKNOWN (AND THERE WAS NO POSSBILITY OF MURDER), AND THE TIME OF DEATH WAS ESTIMATED TO BE ABOUT 7 -10 DAYS BEFORE THE PATIENT WAS FOUND. THE ELAPSED TIME BETWEEN THE SURGERY AND THE PATIENT'S DEATH WAS ABOUT 4 WEEKS. PRIOR TO JOINING THE CLINICAL TRIAL, THE PATIENT HAD BEEN DIAGNOSED WITH STAGE 3 PRIMARY RECTAL CANCER, AND HE HAD UNDERGONE NEOADJUVANT RADIOTHERAPY AND NEOADJUVANT CHEMOTHERAPY (B)(6) 2023), AND HE HAD EXPERIENCED COMPLICATIONS DUE TO GASTRIC ULCERS, HYPERTENSION, NEPHROSCLEROSIS, HEMORRHOIDS AND OVERACTIVE BLADDER. NO AUTOPSY WAS PERFORMED AT THE REQUEST OF THE PATIENT'S RELATIVES. THE PHYSICIAN-IN-CHARGE INDICATED THAT THERE WERE NO OBVIOUS FINDINGS OF ABDOMINAL DISTENSION, NO FINDINGS OF SUSPECTED INTRA-ABDOMINAL HAEMORRHAGE AND NO OBVIOUS VOMITING. THE REPORTING PHYSICIAN INDICATED THAT THE CAUSE OF DEATH WAS UNKNOWN AND THEREFORE, ANY CAUSAL RELATIONSHIP BETWEEN THE DEATH AND THE SURGIWRAP FROST (MEDIUM SIZE) PRODUCT WAS UNKNOWN. HENCE, THERE IS NO DIRECT EVIDENCE TO LINK THE CAUSE OF DEATH OF THE PATIENT TO THE USE OF THE MEDICAL DEVICE, SURGIWRAP FROST BIORESORBABLE FILM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383453 MAST SURGIWRAP FROST BIORESORBABLE SHEET Mesh, surgical, polymeric FTL MAST BIOSURGERY USA, INC. 57302-01 54968

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death AMLODIPINE BESILATE| ENALAPRIL MALEATE| MIRABEGRON| VONOPRAZAN FUMARATE