Events

Alerta De Seguridad para Extractor Pro RX-S

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
    2017-06-05
  • Fecha de publicación del evento
    2017-06-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170605b.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 extractor pro rx-s medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its extractor pro rx-s. the affected devices are identified as follows: product description: 1) extractor pro rx-s injects above 9-12mm; 2) extractor pro rx-s injects below 12-15mm material numbers (upn): 1) m00547300；2) m00547340 batch numbers: 1) 19343203; 2) 19343209 batch expiration date: 30/6/2018 the manufacturer is implementing a voluntary medical device removal on two lots of extractor pro rx-s retrieval balloon catheters. the labeling on the affected devices incorrectly identifies the injection location as “above” the balloon when it should be below the balloon and “below” the balloon when it should be above the balloon. if the injection location is above or below where labeled, then the user will see contrast emerge from the other location, but still within the lumen. this may result in a minor procedure delay due to the need for device exchange. the manufacturer advises users to identify, segregate and return the affected product to the manufacturer. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 june 2017.

Device

Extractor Pro RX-S
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific Extractor Pro RX-S
  • 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