Events

Alerta De Seguridad para Nebulizing Kit

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
    2018-205
  • 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/514564-fda-advisory-no-2018-205
  • 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. 2018-205 public health warning against the purchase and use of unregistered medical devices “nebulizing kit” included on the package of travel nebulizer of far east medical.  the food and drug administration (fda) advises all concerned healthcare professionals, establishment and general consuming public against the purchase and use of the nebulizing kit included in the package of “travel nebulizer” of far east medical whose pictures appear below. fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product 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. pursuant to the provision of 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 any health product that is adulterated, unregistered or misbranded are prohibited.    the abovementioned product did not undergo the evaluation process of the fda. thus, the agency cannot guarantee its quality and safety.  in this regard, the public is hereby advised not to purchase the above-mentioned violative product and to be vigilant against the medical device products that are not registered with fda. distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said medical device product.  for more information and inquiries, please e-mail us at cdrrhr_prsddthis 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. 2018-205.Pdf.

Device

Nebulizing Kit
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP