Events

Alerte De Sécurité sur SURE-GEL (Acidulated Phosphated Fluoride)

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
    2018-100
  • 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/497498-fda-advisory-no-2018-100
  • 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. 2018-100 public  health  warning  against  the   purchase  and  use  of   unregistered  medical   device  sure-gel (acidulated phosphated fluoride) the food and drug administration (fda) hereby advises the public against the purchase and use of the product sure-gel (acidulated phosphated fluoride) whose  particular/details are  provided below:   name of product   name of manufacturer/importer and distributor   status of registration   sure-gel (acidulated phosphated fluoride)   not indicated   unregistered fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of certificate of product registration. pursuant to republic act no. 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited. in this regard, the public is hereby advised not to purchase and use the above-mentioned product  and to be vigilant against the medical device products that are not registered with the fda. all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that these products are not sold in any market. 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 development division – center for device regulation, radiation health and research of the fda at telephone no. (02) 857-1900 loc. 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-100.Pdf.

Device

SURE-GEL (Acidulated Phosphated Fluoride)
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP