BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGEL PLATINUM PLEURAL AIR LEAK SEALANT

    MDR report key: 15904896 · Received December 2, 2022

    Report

    Report Number
    1213643-2022-00774
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 1, 2022
    Report Date
    September 4, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010040
    PMA / PMN Number
    P010047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO CONNECTION THAT COULD BE IDENTIFIED BETWEEN THE USE OF THE PROGEL PLATINUM AND THE PATIENTS REPORTED POSTOPERATIVE COMPLICATION. PNEUMONIA IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT IN LUNG SURGERY. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THIS MDR REPRESENTS THE REPORTED POSTOPERATIVE COMPLICATION OF PATIENT #2. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2022 BASED ON THE INFORMATION PROVIDED. THE SUBJECT PRODUCT PROGEL PLATINUM IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT PROGEL IS MARKETED IN THE US. DEVICE IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 0

    THERE IS NO CONNECTION THAT COULD BE IDENTIFIED BETWEEN THE USE OF THE PROGEL PLATINUM AND THE PATIENTS REPORTED POSTOPERATIVE COMPLICATION. PNEUMONIA IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT IN LUNG SURGERY. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THIS MDR REPRESENTS THE REPORTED POSTOPERATIVE COMPLICATION OF PATIENT #2. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS 01-NOV-2022 BASED ON THE INFORMATION PROVIDED. THE SUBJECT PRODUCT PROGEL PLATINUM IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT PROGEL IS MARKETED IN THE US. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER. 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 PER SALES REP: SALES REP VISITED THE FACILITY AND SPOKE WITH THE SURGEON WHO STATED THAT SHE HAD USED PROGEL PLATINUM ON SEVERAL OCCASIONS (NO EXACT NUMBER). SURGEON STATED THAT IN THE POSTOPERATIVE COMPLICATIONS, THREE PATIENTS PRESENTED WITH PURULENT PNEUMOPATHY. THE ONLY COMMON DENOMINATOR THAT SHE FOUND IN THESE 3 CASES WAS THE USE OF PROGEL PLATINUM, NEVERTHELESS SHE DID NOT INCRIMINATE THE PRODUCT BUT WONDERED. MOREOVER, SHE INFORMED ME THAT HER COLLEAGUES AT THE CLINIC HAD NOT HAD THIS KIND OF PROBLEM.

    Description of Event or Problem · 0

    AS REPORTED PER SALES REP: SALES REP VISITED THE FACILITY AND SPOKE WITH THE SURGEON WHO STATED THAT SHE HAD USED PROGEL PLATINUM ON SEVERAL OCCASIONS (NO EXACT NUMBER). SURGEON STATED THAT IN THE POSTOPERATIVE COMPLICATIONS, THREE PATIENTS PRESENTED WITH PURULENT PNEUMOPATHY. THE ONLY COMMON DENOMINATOR THAT SHE FOUND IN THESE 3 CASES WAS THE USE OF PROGEL PLATINUM, NEVERTHELESS SHE DID NOT INCRIMINATE THE PRODUCT BUT WONDERED. MOREOVER, SHE INFORMED ME THAT HER COLLEAGUES AT THE CLINIC HAD NOT HAD THIS KIND OF PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796615 PROGEL PLATINUM PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI 00801741010040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other