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
    2017-05-16
  • Fecha de publicación del evento
    2017-05-22
  • 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=2017&page=6
  • 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
    Following the notification of the mirena® product 20mcg / 24 hours (lntrauterine system) in which the findings found in lot tu01btw of the product cited in the reference had been communicated and consequently to the corrective and preventive actions carried out, it informs that the lot tu01btw which was blocked in the international warehouses of bayer j. cain, has been 100% inspected, no unit being found with the inserter assembled incorrectly. as seen in the following image, part of the primary packaging material of the product is transparent, so the position of the inserter is easily visualized without contamination of the product, due to the above we confirm that all units of the tu01btw lot were inspected to ensure that the inserter was in the correct position.

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