Alerta De Seguridad para Xinyan Flashlight Earpick

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
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  • 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. 2018-159  public health warning against the purchase and use of unregistered medical device “xinyan flashlight earpick” the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device xinyan flashlight earpick: fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to 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 health products without the proper authorization from fda is prohibited.  accordingly, since this unregistered medical device has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public. in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph. all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.  all local government units (lgus) and law enforcement agencies (leas) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction. for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. , or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.  dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-159.Pdf.


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