Events

Alerta De Seguridad para Mersilene

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Johnson & Johnson Gmbh, Alemania || Ethicon, Inc..

¿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
  • ID del evento
    I1608-351
  • Número del evento
    2008DM-0001417
  • Fecha
    2016-08-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=126
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected that a group of product codes of the referenced device is being supplied with the incorrect user instructions insert (ifu), the product concerned is being delivered with the ifus for mersilene suture, where its indications are different, which could entail to potential confusion between users.

Device

Mersilene
  • Modelo / Serial
    RS20, RS21, RS22, RS23, D10117, D5789, D7164, D8014, D8062, D8113 and D9212, all batches without expiring.
  • Descripción del producto
    It is indicated for the circular suture of the cervix. Ribbons without needles are used to separate or fix the tissues during surgical acts.
  • Manufacturer
    Johnson & Johnson Gmbh, Alemania || Ethicon, Inc.

Manufacturer

Johnson & Johnson Gmbh, Alemania || Ethicon, Inc.