BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRYMILL CROGENIC SYSTEMS

    MDR report key: 3296162 · Received August 12, 2013

    Report

    Report Number
    1216795-2013-00001
    Event Type
    Injury
    Date Received
    August 12, 2013
    Date of Event
    May 22, 2012
    Report Date
    August 8, 2013
    Manufacturer
    BRYMILL CRYOGENIC SYSTEMS
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT AS IT WAS DESCRIBED TO US BY TELEPHONE. THE NURSE WAS FILLING 2 CRYO-SURGICAL UNITS WHEN THE RELIEF VALVE MALFUNCTIONED, BLOWING OUT A LARGE AMOUNT OF LIQUID NITROGEN. THE STREAM WAS SO STRONG THAT IT BLEW OFF HER GLOVES AND BURNT HER HAND. SHE WAS TAKEN TO THE EMERGENCY ROOM, AND IS SEEING A BURN SPECIALIST TODAY. THEY NEED LIQUID NITROGEN, BUT DON'T WANT TO USE THE SUSPECT EQUIPMENT. WE (B)(4) ARE SENDING A NEW 30 LTR DEWAR AND A NEW WITHDRAWAL DEVICE. THEY INFORMED US THAT THEY COULDN'T SEND BACK THE OLD EQUIPMENT BECAUSE (B)(4) AND THEIR WORKERS COMP INSURER WOULD WANT TO EVALUATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385552 BRYMILL CROGENIC SYSTEMS WITHDRAWAL DEVICE GEH BRYMILL CRYOGENIC SYSTEMS 502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization