Alerta De Seguridad para CIDEX OPA Solution

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

¿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
    2015-08-19
  • Fecha de publicación del evento
    2015-08-19
  • País del evento
  • Fuente del evento
    DH
  • 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: advanced sterilization products cidex opa solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex opa solution. the affected product code numbers are 20391 and 20490. the manufacturer conducted a post-market surveillance review of two international complaints for anaphylaxis following medical procedures involving a device disinfected with cidex opa solution. subsequent investigation identified the user failed to follow the rinsing instructions to remove residual cidex opa solution from the medical devices post-processing. improper rinsing may result in the potential for anaphylaxis risk for patient populations beyond bladder cancer patients. the manufacturer advises customers that they may keep their current inventory of cidex opa solution and continue to safely use the product in accordance with the instructions for use, which contain the rinsing instructions. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 august 2015.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX OPA Solution
  • Manufacturer

Manufacturer