BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLATINUM PLEURAL AIR LEAK SEALANT

    MDR report key: 16520368 · Received March 10, 2023

    Report

    Report Number
    1213643-2023-00080
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 14, 2023
    Report Date
    September 5, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010040
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INTENDED USE IN THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, "PROGEL PLATINUM SURGICAL SEALANT IS A SINGLE USE DEVICE INTENDED FOR APPLICATION TO VISIBLE AIR LEAKS ON THE VISCERAL PLEURA AFTER STANDARD VISCERAL PLEURAL CLOSURE TECHNIQUES HAVE BEEN EMPLOYED DURING RESECTION OF LUNG PARENCHYMA." BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT IS A USE ERROR. PROGEL PLATINUM IS NOT APPROVED FOR USE IN THE USA. THIS REPORT IS A SIMILAR DEVICE REPORT FOR PROGEL, WHICH IS APPROVE/MARKETED IN THE USA. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    PER THE INTENDED USE IN THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, "PROGEL PLATINUM SURGICAL SEALANT IS A SINGLE USE DEVICE INTENDED FOR APPLICATION TO VISIBLE AIR LEAKS ON THE VISCERAL PLEURA AFTER STANDARD VISCERAL PLEURAL CLOSURE TECHNIQUES HAVE BEEN EMPLOYED DURING RESECTION OF LUNG PARENCHYMA." BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT IS A USE ERROR. PROGEL PLATINUM IS NOT APPROVED FOR USE IN THE USA. THIS REPORT IS A SIMILAR DEVICE REPORT FOR PROGEL, WHICH IS APPROVE/MARKETED IN THE USA. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER AND UNIQUE IDENTIFIER (UDI). 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, PROGEL (PLATINUM) SURGICAL SEALANT WAS USED IN A GYNECOLOGICAL PROCEDURE PERFORMED IN (B)(6). THE PROGEL PLATINUM SURGICAL SEALANT IS INTENDED FOR APPLICATION TO VISCERAL PLEURA AS AN ADJUNCT TO STANDARD VISCERAL PLEURAL CLOSURE OF VISIBLE AIR LEAKS INCURRED DURING LUNG RESECTION. TO DATE THERE HAS BEEN NO REPORTED ADVERSE PATIENT OUTCOME AS A RESULT OF THIS USE ERROR.

    Description of Event or Problem · 0

    AS REPORTED, PROGEL (PLATINUM) SURGICAL SEALANT WAS USED IN A GYNECOLOGICAL PROCEDURE PERFORMED IN FRANCE. THE PROGEL PLATINUM SURGICAL SEALANT IS INTENDED FOR APPLICATION TO VISCERAL PLEURA AS AN ADJUNCT TO STANDARD VISCERAL PLEURAL CLOSURE OF VISIBLE AIR LEAKS INCURRED DURING LUNG RESECTION. TO DATE THERE HAS BEEN NO REPORTED ADVERSE PATIENT OUTCOME AS A RESULT OF THIS USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922516 PROGEL PLATINUM PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI 00801741010040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other