BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEBAUER'S ETHYL CHLORIDE

    MDR report key: 15448371 · Received September 19, 2022

    Report

    Report Number
    1519179-2022-00001
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    July 14, 2022
    Report Date
    September 19, 2022
    Manufacturer
    GEBAUER COMPANY
    Product Code
    MLY
    PMA / PMN Number
    K190161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED BY THE PATIENT, THE MOST LIKELY CAUSE OF THE INJURY IS DUE TO OVER-APPLICATION OF THE PRODUCT BY THE HEALTHCARE PRACTITIONER THAT RESULTED IN FROSTBITE. THE APPLICATION INSTRUCTIONS PROVIDED WITH THE PRODUCT IDENTIFY TO SPRAY THE TREATMENT AREA WITH THE DEVICE CONTINUOUSLY FOR 3 TO 7 SECONDS FOR THE BOTTLE PRODUCT ( 10 SECONDS FOR THE AEROSOL CAN PRODUCTS) OR UNTIL THE SKIN BEGINS TURNING WHITE, WHICHEVER COMES FIRST. THE PATIENT IDENTIFIED THAT THE DEVICE WAS SPRAYED AND SPRAYED ON THE FOOT AND THE PRACTITIONER CONTINUED TO SPRAY EVEN AFTER THE PATIENT REPORTED PAIN DUE TO THE APPLICATION. THE ADVERSE REACTIONS SECTION OF THE LABELING IDENTIFIES THAT OVER APPLICATION OF THE PRODUCT MAY LEAD TO FROSTBITE. IT SHOULD ALSO BE NOTED THAT THE DEVICE IS NOT INDICATED FOR THE TREATMENT OF FOOT FUNGUS. THE PRODUCT IS INTENDED TO TEMPORARILY CONTROL PAIN ASSOCIATED WITH INJECTIONS AND MINOR SURGICAL PROCEDURES AND THE TREATMENT OF FOOT FUNGUS IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

    Description of Event or Problem · 0

    THE PATIENT (FEMALE) WAS BEING TREATED BY A PODIATRIST FOR FOOT FUNGUS. IT WAS REPORTED THAT THE PATIENT'S ENTIRE FOOT WAS SPRAYED CONTINUOUSLY WITH GEBAUER'S ETHYL CHLORIDE FOR AN EXTENDED PERIOD OF TIME. THE PATIENT IDENTIFIED THAT THEY TOLD THE HEALTHCARE PRACTITIONER THAT THE APPLICATION WAS CAUSING PAIN AND THE PRACTITIONER CONTINUED SPRAYING THE FOOT. PATIENT REPORTED THAT THE RECEIVED A THIRD-DEGREE BURN ON THE FOOT. SYMPTOMS INCLUDED BLISTERS, ITCHINESS, BURNING SENSATION, AND DRAINAGE. REPORTED THAT IT HURT TO WALK. PATIENT HAS RECEIVED TREATMENT FROM A DIFFERENT HEALTHCARE PRACTITIONER FOR 6 WEEKS AND WOUND IS IMPROVING BUT STILL RED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428730 GEBAUER'S ETHYL CHLORIDE VAPOCOOLANT DEVICE MLY GEBAUER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O