BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3964558 · Received May 23, 2014

    Report

    Report Number
    1060680-2014-00018
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 1, 2014
    Manufacturer
    GENICON
    Product Code
    FMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 BAG LEAKED, BUT WAS STILL ABLE TO REMOVE THE SPECIMEN AND EVERYTHING WITH THE SURGERY WENT WELL EXCEPT THE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307390 DEROYAL CONTAINER, SPECIMENT, STERILE FMH GENICON

    Patients

    Seq Age Sex Outcome Treatment
    1