BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GABAUER'S FLURO-ETHYL

    MDR report key: 1150884 · Received August 15, 2008

    Report

    Report Number
    1519179-2008-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    GEBAUER CO.
    Product Code
    MLY
    PMA / PMN Number
    K002596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A UNIT OF GEBAUER'S FLURO-ETHYL MALFUNCTIONED AND THE SKIN REFRIGERANT SPRAYED OUT FROM THE SIDE OF THE VALVE INSTEAD OF SPRAYING FROM THE PRODUCT'S ACTUATOR. FLURO-ETHYL IS PROVIDED IN AN AEROSOL CONTAINER AND CONSISTS OF A CAN, VALVE AND ACTUATOR. THE MALFUNCTIONING UNIT SPRAYED SIDEWAYS AS WELL AS SPRAYING IN THE NORMAL INVERTED POSITION. THE PRODUCT WAS INTENDED TO BE SPRAYED ON THE PT'S UPPER ARM PRIOR TO AN INJECTION, BUT THE MALFUNCTIONING SPRAY CONTACTED THE PT'S NECK AND EAR. NO INJURY WAS REPORTED AS A RESULT OF THE MALFUNCTIONING UNIT. THE PRODUCT IS INTENDED TO CONTACT THE SKIN AND NORMAL INSTRUCTIONS FOR USE, IS TO SPRAY THE PRODUCT ON THE SKIN FOR 2 TO 3 SECONDS FOR PRE-INJECTION ANESTHESIA. INADVERTENT SPRAYING OF THE SKIN FOR 2 TO 3 SECONDS WOULD NOT CAUSE AN INJURY. IF THE MALFUNCTION WERE TO REOCCUR, AND THE PRODUCT INADVERTENTLY SPRAYED INTO THE EYES THERE COULD BE RESULTING INJURY. IT IS UNLIKELY THAT SHORT CONTACT OF THE SKIN REFRIGERANT WITH THE EYES WOULD RESULT IN A SERIOUS INJURY BUT IT COULD POSSIBLY OCCUR. GEBAUER REVIEWED OTHER COMPLAINTS OF INADVERTENT SPRAYING IN THE EYES WITH FUNCTIONING PRODUCT AND NO SERIOUS INJURIES WERE REPORTED. INJURIES OF SPRAYING IN THE EYES IS MOST LIKELY TO RESULT IN AN INJURY THAT IS TEMPORARY AND REVERSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GABAUER'S FLURO-ETHYL FLURO-ETHYL MLY GEBAUER CO. 0386-0002-20 7010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability