BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEBAUER'S ETHYL CHLORIDE MIST SPRAY

    MDR report key: 4736168 · Received April 28, 2015

    Report

    Report Number
    1519179-2015-00001
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    GEBAUER CO.
    Product Code
    MLY
    PMA / PMN Number
    K991514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT AS REPORTED IDENTIFIED THAT THE PT FELT A BURNING SENSATION IMMEDIATELY AFTER THE PRODUCT WAS APPLIED THAT RESULTED IN BLISTERING, SCABBING AND DISCOLORATION. THESE ADVERSE EVENTS ARE TYPICALLY ASSOCIATED WITH FROSTBITE THAT COULD RESULT FROM OVER-APPLICATION OF THE DEVICE. THE COMPLAINANT, WHO DID NOT SPEAK TO THE PT DIRECTLY WAS TOLD THE PRODUCT WAS APPLIED BY A NURSE FOR APPROX 5 SECONDS. A 5 SECOND SPRAY IS WITHIN THE IFU BUT IF THE SKIN HAD TURNED WHITE PRIOR TO THE 5 SECONDS, THE SPRAY SHOULD HAVE BEEN STOPPED PER THE DIRECTIONS FOR USE. ALSO, ALTHOUGH RARE, THE ADVERSE EVENT COULD BE THE RESULT OF AN ALLERGIC REACTION TO ETHYL CHLORIDE OR URTICARIA. GEBAUER WAS TOLD THE PT REQUIRED MEDICAL ATTENTION BUT NO INFO WAS PROVIDED AS TO WAT INTERVENTIONS WERE TAKEN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE UNIT BACK AS WELL AS SEEK FURTHER INFO ON THE INJURY AND THE MEDICAL ATTENTION REQUIRED BUT WE WERE INFORMED THE PRODUCT WOULD NOT BE RETURNED AND NO FURTHER INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    THE PT WAS RECEIVING DIALYSIS AND GEBAUER'S ETHYL CHLORIDE MIST SPRAY (LOT 3068) WAS APPLIED FOR PRE-INJECTION ANESTHESIA. THE PT REPORTED BURNING, BLISTERING, SCABBING AND DISCOLORATION AFTER APPLICATION OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279053 GEBAUER'S ETHYL CHLORIDE MIST SPRAY CAPOCOOLANT MLY GEBAUER CO. 0386-0001-02 3068

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization