Events

Alerta De Seguridad para Hydrogen Water Generator

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
    2018-176
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/508923-fda-advisory-no-2018-176
  • 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. 2018-176 public health warning against non-certified therapeutic claims on the advertisement and promotion of hydrogen water generator the food and drug administration (fda) warns the public against non-certified therapeutic claims on the advertisement and promotion of hydrogen water generator: among the unsubstantiated health claims used on the said product are as follows: helps cure and fight wide range of diseases, boosts immune system; anti-aging, anti-wrinkle; act as therapeutic antioxidant; helps prevent brain injuries, heart disease and age related memory loss; improves concentration; prevents cancer and diabetes; strengthen immune system; and enhance immune system of children  therapeutic claims made on drinking water must be substantiated through valid clinical trial. the above health claims used in the advertisement of the said product have not been validated and approved by the fda. sale, distribution and advertisement of health products without prior approval from the fda is a violation of the provisions of republic act 9711 or the food and drug administration (fda) act of 2009.  the public is hereby advised not to fall prey to distributors and retailers of the said product and to be vigilant and observe precautionary measures in purchasing products with misleading and deceptive health claims.  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 center for device regulation, radiation health and research hotline at (02) 857-1900 local 8301.  dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-176.Pdf.

Device

Hydrogen Water Generator
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP