Events

Alerta De Seguridad para FindrWIRZ Guidewire System

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

¿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
    2016-11-23
  • Fecha de publicación del evento
    2016-11-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161123.html
  • 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: sentreheart findrwirz guidewire system medical device manufacturer, medimaps, has issued a medical device safety alert concerning its tbs insight [software version v.3.0.1]. the united states food and drug administration (fda) has issued medical device safety alerts concerning findrwirz guidewire system, manufactured by sentreheart [product code: 40-05; lot numbers: 01160568, 02160568 and 07160639-150; manufactured between 4 january and 22 july 2016]. the manufacturer is recalling the findrwirz guidewire system because the polytetrafluoroethylene (ptfe) coating may separate (e.G. peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. coating separation may be caused by issues with the device design or manufacturing processes. small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death. affected users are recommended to take the following actions: identify and stop using the affected products. return the affected products to the manufacturer immediately. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm530413.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm530336.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 november 2016.

Device

FindrWIRZ Guidewire System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SentreHEART FindrWIRZ Guidewire System
  • Manufacturer
    Medimaps

Manufacturer

Medimaps
  • Source
    DH