Alerta De Seguridad para Doyen-Collin Mouth Gag 120mm

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

¿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
    2018-02-14
  • Fecha de publicación del evento
    2018-02-14
  • 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: aesculap ag doyen-collin mouth gag 120mm medical device manufacturer, aesculap ag, has issued a medical device safety alert concerning its doyen-collin mouth gag 120mm [om040r; production period from february 2016 to october 2017]. an affected product om040r can be clearly identified by two options: identification on the basis of the labelled production date (from 02 16 to 10 17 inclusively), identification on the basis of the labelled encoding (from 000330 to 000449 inclusively). the manufacturer received knowledge about the possibility that the plastic sleeves of a doyen-collin mouth gag 120mm - om040r could stick together after reprocessing. according to the manufacturer, the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing. the results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 february 2018.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Aesculap AG Doyen-Collin Mouth Gag 120mm
  • Manufacturer

Manufacturer