BEUDAMED
    FDA Adverse Event Summary report: N

    ETHYL CHLORIDE

    MDR report key: 8185477 · Received December 20, 2018

    Report

    Report Number
    MW5082319
    Date Received
    December 20, 2018
    Report Date
    December 20, 2018
    Manufacturer
    GEBAUER COMPANY
    Product Code
    MLY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GEBAUER'S ETHYL CHLORIDE SPRAY WAS APPLIED TO PT'S GREAT TOE. ELECTRICAL CAUTERY WAS SUBSEQUENTLY USED, CAUSING IGNITION. THE PROVIDER WAS ABLE TO QUICKLY SMOTHER FLAME, ALTHOUGH PT SUFFERED FIRST DEGREE BURN ON HIS TOE AND IS NOW UNDERGOING WOUND CARE FOR THIS. THE PRODUCT LABEL DOES HAVE A SMALL FLAME AND WARNING OF NOT USING ELECTRICAL CAUTERY, HOWEVER, THE PROVIDER DID NOT NOTICE THESE WARNINGS AND OR KNOW ABOUT THIS RISK. DATE RECEIVED 01/29/2018. DOSAGE FORM: SPRAY. (B)(6). ACCESS NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026113 ETHYL CHLORIDE REFRIGERANT, TOPICAL (VAPOCOOLANT) MLY GEBAUER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1