Alerta De Seguridad para Bravo pH capsule delivery devices for Bravo pH Monitoring System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic bravo ph capsule delivery devices for bravo ph monitoring system medical device manufacturer, medtronic, has issued a medical device safety alert concerning all lots of its bravo ph capsule delivery devices for bravo ph monitoring system [fgs-0312 (5-pack) and fgs-0313 (1-pack)] according to the manufacturer, it has received three reports from customers related to patients having allergic reactions to the nickel content in the stainless steel trocar needle that attaches the bravo capsule to the esophageal mucosa. allergic reactions can include hives, itching or oral numbness. there have been no reports of serious injury related to this safety notice. the manufacturer is adding the following statement to the bravo ph monitoring system user manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity. the bravo capsule contains a trocar needle that is made of stainless steel. use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. the bravo ph test lasts from 48-96 hours. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 april 2016.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Bravo pH capsule delivery devices for Bravo pH Monitoring System
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source