Events

Alerta De Seguridad para PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating

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

¿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
    2016-03-30
  • Fecha de publicación del evento
    2016-03-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160330.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: boston scientific pt graphix magnet j-tip guidewire with ice hydrophilic coating medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its pt graphix magnet j-tip guidewire with ice hydrophilic coating [material number (upn): h7491490201mj25pk and h7491490201mjo; lot number: 17971870; expiration date: 10-may-2017]. the manufacturer has found that, while the batch is labeled as a j-tip model, the guidewires are straight and do not have the pre-formed j-tip. the most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has a j-tip. no patient injuries have been reported. product recall is ongoing. the manufacturer instructs affected users to stop distributing or using any remaining products affected by this recall immediately. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 march 2016.

Device

PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH