BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 20268327 · Received September 20, 2024

    Report

    Report Number
    1213643-2024-00461
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 5, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, MOLD INSIDE PROGEL PRODUCT CARTON WAS NOTED. PHOTO REVIEW AND EVALUATION OF RETURNED SAMPLE CONFIRMS THE OUTER PART OF THE CARTON APPEARS TO HAVE SOME DAMAGE/CREASING CONSISTENT WITH SOME DISCOLORATION (YELLOW IN COLOR) ALONG THE EDGES OF THE CARTON AND DISCOLORATION (BLACK IN COLOR, SPOTTY) ON THE INSIDE OF THE CARTON OPENING FLAP, ON THE IFU BOOKLET AND PATIENT TRACE LABELS WHICH IS LIKELY MILDEW/MOLD. THE SAME DISCOLORATION CAN BE SEEN ON THE TYVEK LIDS OF THE BLISTER TRAYS. THE PROGEL PRODUCT CARTON IS WATER DAMAGED. BASED ON AS RECEIVED CONDITION AND REPORTED EVENT, THE CAUSE FOR THE WATER DAMAGE WAS THE PRODUCT CARTON AND ITS CONTENTS WERE EXPOSED TO WATER/MOISTURE DURING STORAGE AT THE USER FACILITY OVER SEVERAL MONTHS. TO DATE THIS IS THE ONLY REPORTED COMPLAINT FOR THIS LOT. 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, UPON OPENING THE PROGEL UNIT FOR A CASE, IT WAS DISCOVERED THAT THERE WAS WHAT APPEARED TO BE MOLD INSIDE THE CONTAINER AND THE OUTSIDE PACKAGE HAD SOME OBVIOUS WATER SPOTS. IT WAS REPORTED THAT THE PRODUCT WAS STORED IN REFRIGERATOR WITH TEMPERATURE BETWEEN 36°F AND 46°F FOR SEVERAL MONTHS. IT WAS ALSO REPORTED THAT SOME CONDENSATION IN THE BACK OF REFRIGERATOR WAS NOTED AND HAD SOME WATER PUDDLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309240 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IRJP0024 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other