BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER NITROSPRAY REGULAR PLUS 16 OZ.

    MDR report key: 518149 · Received March 26, 2004

    Report

    Report Number
    2521453-2004-00004
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    February 19, 2003
    Report Date
    May 29, 2003
    Manufacturer
    PREMIER MEDICAL (MFG)
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NITROSPRAY REGULAR PLUS, CYROSURGERY UNIT WAS USED BY THE LPN. NURSE FILLED THE UNIT THAT WAS INVOLVED IN A LEAKING INCIDENT, NURSE THEN REACHED FOR THE UNIT TO LIFT IT FROM A STATIONARY POSITION WHEN THE O-RING BLEW AND EXPOSED THEIR HAND TO LIQUID NITROGEN GAS. THE INCIDENT RESULTED IN THE LPN EXPERIENCING A BURNING SENSATION WHICH WAS ACCOMPANIED BY NUMBNESS TO THE HAND. NO MEDICAL TREATMENT WAS REQUIRED AFTER THE INCIDENT HAD OCCURRED, THERE WAS NO BLISTERING INVOLVED AND NO FOLLOW UP TREATMENT NECESSARY. THE LPN WAS WEARING THIN LATEX GLOVES AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIER NITROSPRAY REGULAR PLUS 16 OZ. CRYOSURGERY DEVICE GEH PREMIER MEDICAL (MFG) REGULAR PLUS 16 OZ. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention