Events

Alerte De Sécurité sur Bebeta Digital Thermometer

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
    2018-197
  • 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/514542-fda-advisory-no-2018-197
  • 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. 2018-197 public health warning against the purchase and use of unregistered medical device (bebeta digital thermometer) the food and drug administration (fda) advises all concerned healthcare professionals and the public against the purchase and use of bebeta digital thermometer: fda post-marketing surveillance activities have verified that the above-mentioned medical device has not gone through the registration process of the agency and has not been issued with certificate of product registration (cpr). pursuant to the provisions of  republic act 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 any health product without the proper authorization are prohibited.  since the abovementioned product did not undergo the evaluation process of the fda, the agency cannot guarantee its quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative product. all concerned establishments are warned not to advertise, sell or distribute the said product until such has been issued with the corresponding cerificate of product registration, otherwise, regulatory actions and sanctions shall be strictly pursued. all local government units (lgus) and law enforcement agenies (leas) are requested to ensure that the product is not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please email the 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 at (02) 857-1900 local 8301.  dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-197.Pdf.

Device

Bebeta Digital Thermometer
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP