BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 21211619 · Received January 22, 2025

    Report

    Report Number
    1213643-2025-00017
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 24, 2025
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010026
    PMA / PMN Number
    P010047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, PATIENT HAD SUBCUTANEOUS EMPHYSEMA POST USAGE OF PROGEL. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE PROGEL USED IN THE PROCEDURE MAY HAVE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. 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."

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA POST USAGE OF PROGEL. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST PROBABLE CAUSE ME BE THE INADVERTENTLY CLOGGING OF A TUBE BY THE SURGEON. BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE AS TO WHAT IF ANY EXTENT THE PROGEL CAUSED OR CONTRIBUTED TO POST OPERATIVE SUBCUTANEOUS EMPHYSEMA. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT THE DESCRIBE EVENT OR PROBLEM, IMDRF ANNEX E AND IMDRF ANNEX B CODE. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES SUBCUTANEOUS EMPHYSEMA AS A POSSIBLE COMPLICATION. 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

    AS REPORTED, THE SURGEON RESPONDED TO THE SALES REP'S FOLLOW UP ON HER EXPERIENCE USING THE PRODUCT PROGEL. THE SURGEON EXPLAINED THAT DURING THE SUMMER IN 2024 AFTER USE OF PROGEL SHE HAD A PATIENT WHO POST OPERATIVELY EXPERIENCED SUBCUTANEOUS EMPHYSEMA. THE SURGEON DID NOT PROVIDE ANY MORE DETAIL ABOUT THE SPECIFIC CASE.

    Description of Event or Problem · 0

    AS REPORTED, PROGEL CLOGGED A TUBE, AND THE PATIENT ENDED UP HAVING SIGNIFICANT SUBCUTANEOUS EMPHYSEMA. THE SURGEON EXPLAINED THAT DURING THE SUMMER IN (B)(6) 2024 AFTER USE OF PROGEL SHE HAD A PATIENT WHO POST OPERATIVELY EXPERIENCED SUBCUTANEOUS EMPHYSEMA. THE SURGEON DID NOT PROVIDE ANY MORE DETAIL ABOUT THE SPECIFIC CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738619 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention