BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3964555 · Received May 23, 2014

    Report

    Report Number
    1060680-2014-00013
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    GENICON
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THE MANUFACTURER, (B)(4), HAS BEEN MADE AWARE OF THE ISSUE. INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    THE HEAT SEAL FROM THE TIP OF THE BAG BUSTED OPEN AT THE TIP, CAUSED BY THE PRESSURE BUILT FROM REMOVING THE BAG WITH THE GALLBLADDER IN THE POUCH FROM THE SMALL INCISION. THE BAG'S SEAM WAS MAINTAINED, ALTHOUGH BILE WAS SEEPING FROM THE TIP SINCE THE HEAT SEAL HAD BROKEN. SUCTION IRRIGATION WAS USED TO ENSURE ALL BILE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307303 DEROYAL CONTAINER, SPECIMEN, STERILE FMH GENICON

    Patients

    Seq Age Sex Outcome Treatment
    1