Events

Alerta De Seguridad para Mirena

Según Health Ministry (Panama), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Panama que fue producido por Bayer Pharma 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
    2016-06-16
  • Fecha de publicación del evento
    2016-07-12
  • País del evento
    Panama
  • Fuente del evento
    HMP
  • URL de la fuente del evento
    http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2016&page=1
  • Notas / Alertas
    Panamanian data is current through January 2019. All of the data comes from the Health Ministry (Panama), 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 recall data from the U.S. and Panama.
  • Notas adicionales en la data
  • Causa
    The australian regulatory medicines agency, the therapeutic goods administration (tga), has announced that intrauterine device (iud) information containing 52 mg of levonorgestrel (mirena®) will be reviewed to include information regarding an increased risk of uterine perforation for breastfeeding women during the first 36 weeks after delivery. while it is known that uterine perforation is a rare adverse event associated with the use of intrauterine contraceptive devices, a recent european study has found that the risk of uterine perforation increases in nursing women and during the first 36 weeks after delivery.

Device

Mirena
  • Modelo / Serial
  • Descripción del producto
    Mirena® is an intrauterine device that contains levonorgestrel, a progestagen with antiestrogenic activity, that releases 20 µg of the hormone every 24 hours directly into the intrauterine cavity.
  • Manufacturer
    Bayer Pharma AG

Manufacturer

Bayer Pharma AG
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    HMP