BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGEL PLATINUM PLUERAL AIR LEAK SEALANT

    MDR report key: 23268243 · Received October 10, 2025

    Report

    Report Number
    1213643-2025-00975
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    July 1, 2023
    Report Date
    September 25, 2025
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    PMA / PMN Number
    P010047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE AUTHORS REPORT ONE POST-OPERATIVE DEATH IN THE GROUP OF PATIENTS THAT A PROGEL WAS UTILIZED WITH THE INTENTION TO REDUCE POST-OPERATIVE AIR LEAKS. BASED ON THE EVALUATION OF THE PUBLICATION AUTHORS, THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO A MASSIVE HAEMOTHORAX 20 DAYS POST-SURGERY. THERE IS NO INFORMATION PROVIDED IN THIS ARTICLE THAT WOULD SUGGEST THE POST-OPERATIVE DEATH WAS DIRECTLY OR INDIRECTLY RELATED TO PROGEL. FURTHER IN THE DISCUSSION SECTION THEY CONCLUDE THAT THE USE OF THE SEALANT WAS NOT ASSOCIATED WITH INCREASED COMPLICATIONS OR ANY SIDE EFFECT; AND THAT THEY DID NOT OBSERVE IMMUNOGENIC OR DEVICE-RELATED RESPONSE, AND NO PATIENT INCLUDED IN THE SEALANT GROUP DEVELOPED EMPYEMA OR MICROBIOLOGICAL COMPLICATIONS. REVIEW OF THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, IDENTIFIES PNEUMOTHORAX AND PLEURAL EFFUSION AS POSSIBLE ADVERSE REACTIONS AND ARE CONSIDERED FORESEEABLE AND CLINICALLY ACCEPTABLE IN TERMS OF PATIENT BENEFIT. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JUL-2023) IS CONSIDERED TO BE A BEST ESTIMATE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: AIR LEAKS MANAGEMENT USING POLYMERIC HYDROGEL MATRIX AFTER THORACOSCOPIC LUNG SEGMENTECTOMY: A SINGLE CENTER PROSPECTIVE RANDOMIZED TRIAL WITH A COST-EFFECTIVE ANALYSIS. THIS MONOCENTRIC PROSPECTIVE RANDOMIZED STUDY WAS CONDUCTED WITH 60 PATIENTS WHO UNDERWENT LUNG SEGMENTECTOMIES (SIMPLE OR COMPLEX) VIA VIDEO ASSISTED THORACIC SURGERY (VATS) WITH INTRAOPERATIVE EVIDENCE OF MODERATE POST PROCEDURAL AIR LEAKS FROM (B)(6) 2023 TO (B)(6) 2024 AT UNIVERSITY HOSPITAL OF PADOVA. PATIENTS WERE RANDOMIZED INTO TWO GROUPS: POLYMERIC HYDROGEL MATRIX (PHM GROUP 30) AND STANDARD CARE (SC GROUP 30). THE 30 PATIENTS (17 FEMALE AND 13 MALE) IN THE PHM GROUP RECEIVED A SINGLE KIT OF PROGEL PLATINUM SEALANT. IN PHM GROUP, PATIENTS HAD POST OPERATIVE COMPLICATIONS SUCH AS PNEUMOTHORAX (1), PLEURAL EFFUSION (1), PROLONGED AIR LEAK (3). THERE WAS A SINGLE POSTOPERATIVE DEATH, DUE TO A MASSIVE HEMOTHORAX 20 DAYS AFTER DISCHARGE. THIS ARTICLE CONCLUDED THAT THE PHM APPLICATION IN THORACOSCOPIC LUNG SEGMENTECTOMIES WITH MODERATE INTRAOPERATIVE AIR LEAKS SIGNIFICANTLY REDUCES POSTOPERATIVE AIR LEAKS, CHEST TUBE DURATION, AND HOSPITAL STAY. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936109 PROGEL PLATINUM PLUERAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other