Alerta De Seguridad para WariActiv Vapo Coolant Anesthesia Aerosol Spray, Ethyl Chloride

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por N/A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2017-086 public health warning against misuse of wariactiv® vapo coolant anesthesia aerosol spray, ethyl chloride the food and drug administration (fda) advises the public against the misuse of wariactiv® vapo coolant anesthesia aerosol spray, ethyl chloride (please see picture below). the said product is a registered medical device and was approved as local skin anesthesia. however, the fda received reports that the product is being indiscriminately used by some individuals. the product is being misused by inhaling it to feel “high” or happy. the abuse and misuse of the product’s active ingredient, ethyl chloride, could lead to the following adverse effects: acute (short-term) inhalation exposure to high levels of ethyl chloride in humans has resulted in temporary feelings of drunkenness, dizziness, lack of muscle coordination and unconsciousness.* chronic (long-term) effects include ataxia (uncoordinated movements), tremors, speech difficulties, slowed reflexes, involuntary eye movement, and hallucinations, and liver effects were reported in individuals who purposely inhaled very high concentrations of ethyl chloride for a few months.* sudden sniffing death syndrome**                                                               in the interest of protecting public health and safety from adverse health effects brought about by the abuse and misuse of the product, the public is hereby advised to use the product only in accordance with its approved use. likewise, advertisement of the product in all forms of media other than its approved use is prohibited. retailers are also advised to avoid indiscriminate selling of the product to customers. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. references: 1. united states environmental protection agency website*                          (https://www.Epa.Gov/sites/production/files/2016-09/documents/ethyl-chloride.Pdf)                   2. dr. lynn crisanta r. panganiban, professor, department of pharmacology & toxicology, up college of medicine/consultant, national poison management & control center, up college of medicine – philippine general hospital** attachments: fda advisory no. 2017-086.Pdf.


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