Events

Alerta De Seguridad para Treanda injection

Según Health Ministry (Panama), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Panama que fue producido por Teva Pharmaceuticals.

¿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
    2015-06-09
  • Fecha de publicación del evento
    2015-06-16
  • 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=2015&page=2
  • 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 fda warns health professionals not to use treanda lnjection (45 mg i 0.5 ml or 180 mg i 2 ml solution) with closed system transfer devices (cctd), adapters and syringes containing polycarbonate or acrylonitrile- butadiene-styrene (abs). most commercialized cstds contain polycarbonate or abs and are not compatible with treanda injection (45 mg i 0.5 ml or 180 mg i 2 ml solution). n, n-dimethylacetamide (oma), an ingredient in treanda injection (45 mg i 0.5 ml or 180 mg i 2 ml solution), is incompatible with polycarbonate or abs. devices containing polycarbonate or abs dissolve when they come into contact with oma. this can lead to device failure, possible product contamination and possible serious adverse health consequences, including skin reactions in health professionals who prepare and administer this product; and the risk of small obstruction of blood vessels in patients.

Device

Treanda injection

Manufacturer

Teva Pharmaceuticals