Events

Alerte De Sécurité sur Hydrogen Water Generator

Selon Food and Drug Administration Philippines, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Philippines qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    2018-176
  • Pays de l'événement
    Philippines
  • Source de l'événement
    FDAP
  • URL de la source de l'événement
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/508923-fda-advisory-no-2018-176
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP