BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 22748973 · Received August 8, 2025

    Report

    Report Number
    1213643-2025-00743
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 4, 2025
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010026
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, PROGEL PLEURAL AIR LEAK SEALANT GLASS VIAL BROKE PRIOR TO APPLICATION. THE SUBJECT DEVICE HAS BEEN DISCARDED. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSION CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. 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, DURING A ROBOTIC WEDGE RESECTION PROCEDURE THE PROGEL PLEURAL AIR LEAK SEALANT GLASS VIAL CRACKED PRIOR TO APPLICATION. THE PRODUCT WAS USED WITHIN 20 MINUTES OF MIXING THE PRODUCT. THE PRODUCT WAS DISCARDEDTHE SURGEON AND OR STAFF ARE FAMILIAR WITH USING THE PROGEL PRODUCT AND DID NOT USE EXCESSIVE FORCE WHEN APPLYING THE PRODUCT. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249542 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IRKQ0053 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other