BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 5077242 · Received September 15, 2015

    Report

    Report Number
    5077242
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 28, 2015
    Manufacturer
    NEOMEND, INC.
    Product Code
    NBE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REGISTERED NURSE FIRST ASSISTANT (RNFA) PREPARED THE PROGEL ASSEMBLY SYRINGE PER MANUFACTURER INSTRUCTIONS. WHEN THE SURGEON ATTEMPTED TO ADMINISTER THE PROGEL, THE PROGEL DID NOT GO OUT OF THE TIP, BUT SHOT OUT THE BACK. THE TIME WAS WELL UNDER THE 20 MINUTE TIME TO USE THE PRODUCT. PRODUCT MIXED IN LESS THAN 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610425 PROGEL PLEURAL AIR LEAK SEALANT SEALANT,POLYMERIZING NBE NEOMEND, INC. 150610-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NO