BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3964561 · Received May 23, 2014

    Report

    Report Number
    1060680-2014-00015
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 1, 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 SPECIMEN BAG SPLIT DOWN THE SEAM WHILE TRYING TO REMOVE THE SPECIMEN. THIS WAS THE FIRST TIME THE BAG HAD RIPPED. HOWEVER, IN ADDITION TO THE RIPPLING OF THE BAG, WITHIN THE LAST COUPLE OF WEEKS LEAKING AHS BEEN EXPERIENCED ALONG THE SEAM IN OTHER CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307304 DEROYAL CONTAINER, SPECIMEN, STERILE FMH GENICON

    Patients

    Seq Age Sex Outcome Treatment
    1