Events

Alerta De Seguridad para Safil and Novosyn

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

¿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
    2018-06-13
  • Fecha de publicación del evento
    2018-06-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180613b.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: b. braun surgical, s.A safil and novosyn medical device manufacturer, b. braun surgical, s.A, has issued a medical device safety alert concerning its safil and novosyn, sterile absorbable surgical multifilament suture. from an internal non-conformity, the manufacturer detected that some units of the mentioned products have the pack damaged; as a consequence the product sterility is compromised. according to the manufacturer, wound infection (e.G. endomyometritis, localized/generalized peritonitis), abscess formation, adhesions, risk of wound dehiscence, sepsis that could lead to life-threatening injury. treatment or reoperation might be necessary. the manufacturer would not recommend any specific monitoring of the patients that have been treated with the involved products since there is a risk of infection innate in any type of surgery. the hospital should act according to their established protocol for such complications. affected users are instructed to identify and quarantine if the affected product in their warehouse. product recall is on-going. according to the local supplier, 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 13 june 2018.

Device

Safil and Novosyn
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: B. Braun Surgical, S.A Safil and Novosyn
  • Manufacturer
    B

Manufacturer

B