Events

Alerta De Seguridad para Trojan Latex Condom

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
    2018-115
  • 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/498913-fda-advisory-no-2018-115
  • 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. 2018-115 public health warning against the purchase and use of medical devices (condoms) that are unregistered and with expired certificate of product registration the food and drug administration (fda) advises the public against the purchase and use of the following medical device products: post-marketing surveillance activities conducted by the fda have verified that trojan latex condom - thin mince (see figure 1) has not gone through the registration process of the agency and has not been issued with certificate of product registration (cpr). furthermore, it was found out that the cpr of trojan latex condom - naked sensations fire & ice (see figure 2) was already expired. 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 products did not undergo the evaluation process of the fda, the agency cannot guarantee their quality and safety. in this regard, the public is hereby advised not to purchase the above-mentioned violative products. all concerned establishments are warned not to advertise, sell or distribute the said products until such have 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 these products are not sold or made available in their localities or areas of jurisdiction. 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 us at the center for device regulation, radiation health and research hotline 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-115.Pdf.

Device

Trojan Latex Condom
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP