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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: coopersurgical single-use cpo-6 colpo-pneumo occluder medical device manufacturer, coopersurgical, has issued a medical device safety alert concerning its single-use cpo-6 colpo-pneumo occluder [part number: cpo-6; lot numbers: 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247609, 247610, & 248112] the manufacturer is recalling 26 lots of the affected product due to the possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. this condition was detected during a complaint investigation unrelated to the packaging seal. there have not been any adverse events reported to coopersurgical due to this potential issue. the manufacturer has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. according to the manufacturer, a product is acceptable for use if it is visually confirmed that the pouch’s seal is intact. as indicated in the directions for use, each package should be handled with care and inspected for damage, including the seal area before use. the affected users are advised to inspect the package contents and the sterile seal along the entire periphery of the package. they should discontinue use of the product with any packaging irregularities and quarantine the product, product replacement is on-going. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 september 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CooperSurgical SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER
  • Manufacturer