Alerta De Seguridad para Eluting Coronary Stent System

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

¿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
    2015-06-22
  • Fecha de publicación del evento
    2015-06-22
  • País del evento
  • Fuente del evento
    DH
  • 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: orsiro sirolimus eluting coronary stent system medical device manufacturer, biotronik, has issued a medical device safety alert concerning its orsiro sirolimus eluting coronary stent system [reference numbers: 391240 & 391241; lot numbers: 02152670, 02152671, 02152672, 02152673]. according to the manufacturer, four lots of the orsiro stent system had been wrongly labeled. the labeled diameter does not reflect the actual diameter of the packed product. the use of a product from the affected lots may result in vessel injury and/or increased procedure time. users are advised to discontinue any further use of the affected products. according to the local supplier, only one lot [reference number: 391241 and lot number: 02152673] of the affected products had been imported and distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2015.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Orsiro Sirolimus Eluting Coronary Stent System
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DH