Events

Alerta De Seguridad para TWISTER Rotatable Polyp Retrieval Device

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

¿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
    2011-10-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111018a.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
    Field safety notice: boston scientific twistertm rotatable polyp retrieval device medical device supplier, boston scientific corporation, issued an urgent customer notification concerning twistertm rotatable polyp retrieval device. below is the list of affected products. all of them are expired on 30 november 2013. product description lot/batch number twister polyp retrieval – 13mm (box 5) h10081204, h10081206 twister polyp retrieval – 13mm (box 10) h10081215, h10091601, h10091602 twister polyp retrieval – 32mm (box 1) h10081255, h10081256 there is a labeling issue for twistertm rotatable polyp retrieval device that the inner pouch listed an incorrect upn number and basket size. however the outer box upn and basket size is correct for the device. according to the local supplier, hk is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

TWISTER Rotatable Polyp Retrieval Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific TWISTERTM Rotatable Polyp Retrieval Device
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 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