BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 23265953 · Received October 10, 2025

    Report

    Report Number
    1213643-2025-00974
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    November 1, 2020
    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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED POST OPERATIVE COMPLICATIONS. THERE IS NO INFORMATION PROVIDED IN THIS ARTICLE THAT WOULD SUGGEST THE POST-OPERATIVE COMPLICATIONS WERE DIRECTLY OR INDIRECTLY RELATED TO PROGEL. AS REPORTED BY THE CO-AUTHOR, THE POST OPERATIVE COMPLICATIONS WERE NOT RELATED TO THE PROGEL AND IT WAS USED ALONG WITH THE MESH TO IMPROVE AIR LEAK CONTROL EVEN MORE THAN WITH PROGEL ALONE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-NOV-2020) 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: IMPLANTATION OF POLYGLYCOLIC ACID MESH OVER LUNG RESECTION STAPLE LINES TO PREVENT AIR LEAKS. A TOTAL OF 250 PATIENTS WERE ANALYZED FOR POSTOPERATIVE AIR LEAKS 125 PATIENTS RECEIVED A DOUBLE LAYER OF ABSORBABLE POLYGLYCOLIC ACID MESH ALONG WITH 1 VIAL OF PROGEL LUNG SEALANT AND 125 PATIENTS DID NOT RECEIVE MESH AND WERE TREATED WITH 2 VIALS OF PROGEL LUNG SEALANT. DURING THE 6-MONTH POSTOPERATIVE SURVEILLANCE IT WAS OBSERVED THAT, THE MESH COHORT GROUP EXPERIENCED 15 COMPLICATIONS, INCLUDING PNEUMONIA (2), AIR LEAK > 2 DAYS (8), ATRIAL ARRHYTHMIA (5 CASES) AND THE NON-MESH COHORT GROUP EXPERIENCED 21 COMPLICATIONS, INCLUDING PNEUMONIA (1), AIR LEAK > 2 DAYS (13), REOPERATION FOR COMPLICATIONS (2), BLEEDING REQUIRING TRANSFUSION (1), RESPIRATORY INSUFFICIENCY/BIPAP/REINTUBATION (1), CHYLOTHORAX (1), ATRIAL ARRHYTHMIA (2). CONCLUSION: PLACING A DOUBLE LAYER OF POLYGLYCOLIC ACID MESH OVER THE PARENCHYMAL STAPLE LINES IN MAJOR LUNG RESECTIONS IS A SAFE AND EFFECTIVE ADJUNCT TO REDUCE POSTOPERATIVE AIR LEAKS, RESULTING IN A SIGNIFICANT DECREASE IN HOSPITAL LENGTH OF STAY. ADDENDUM PER COAUTHOR: "WE DID NOT EXPERIENCE COMPLICATIONS WITH THE PRO GEL AND I CONTINUED TO USE IT THROUGHOUT THE COURSE OF THIS RETROSPECTIVE STUDY. I USED THE PRO GEL TO HOLD THE MESH ONTO THE STAPLE LINES AND IT IMPROVED OUR EXPERIENCE WITH IMPROVED PNEUMOSTASIS. AGAIN, WE DID NOT HAVE COMPLICATIONS WITH PRO GEL--WE JUST ADDED THE USE OF THE MESH TO IMPROVE AIR LEAK CONTROL EVEN MORE THAN WITH PRO GEL ALONE." 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
    1936991 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention