Events

Alerta De Seguridad para IF Electrostatic Therapy Device

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
    2018-259
  • 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/525482-fda-advisory-no-2018-259
  • 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. 2018-259 public health warning against the unapproved and misleading advertisements and promotion of if electrostatic therapy device the food and drug administration (fda) warns the public against the unapproved, false and misleading advertisements and promotion of if electrostatic therapy device monitored from flyer collected from ok dok  at 43 annapolis tower greenhills  san juan. the public is hereby warned that the aforementioned claims were not duly approved by the fda. any health device products should not bear any misleading, deceptive and false claims in their labels and/or any promotional materials that will provide erroneous impression on product’s character and identity. hence, false and misleading advertisement of health devices may harm and cause potential risk to the consumers. on the other hand, the false, deceptive and misleading advertisement of these health devices, constitutes violation of title iii, chapter i of the republic act no. 7394, otherwise known as the consumer act of the philippines of 1992.  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.   attachments: fda advisory no. 2018-259.Pdf.

Device

IF Electrostatic Therapy Device
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP