Events

Alerta De Seguridad para ALAIR Bronchial Thermoplasty Catheter

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
    2013-05-31
  • Fecha de publicación del evento
    2013-05-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130531a.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 alair bronchial thermoplasty catheter medical device manufacturer, boston scientific, has issued a field safety notice concerning alair bronchial thermoplasty catheter with: material no.: m005ats25010 catalogue no.: ats 2-5 lot/batch no.: cm040212 expiration date: apr 2014 according to boston scientific, it has discovered an inconsistent “use by” expiration date on a single lot/batch of alair bronchial thermoplasty catheters. the expiration date is listed in two locations on the packaging of the product; the outer box label and the inner tray label. the expiration date on the outer box label, 2014-04, is correct. however, the expiration date on the inner tray, 2012-04, is incorrect. the actual product expiration date is 2 years beyond the incorrect date on the inner tray label. there is no patient risk related to the incorrect date on the inner tray label since the product is not actually expired. the manufacturer advises users that they can continue to use the device until the expiration date on the outer box label, 20 14-04. according to the local supplier, affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 may 2013.

Device

ALAIR Bronchial Thermoplasty Catheter
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific ALAIR Bronchial Thermoplasty Catheter
  • 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