Events

Alerta De Seguridad para Silicone pessaries / Gynecological pessary

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 Coopersurgical 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
    R1705-157
  • Número del evento
    2015DM-0014123
  • Fecha
    2017-05-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 informs that the secondary packaging box of the referenced devices is marked as latex free product, generating a high risk of a severe allergic reaction for the users allergic to latex, leading to potential adverse events on the patients.

Device

Silicone pessaries / Gynecological pessary
  • Modelo / Serial
  • Descripción del producto
    Unless otherwise specified in the instructions, it is recommended that the placement be performed by medical personnel. Uses: pespesarios are used as support for certain pelvic organs that have suffered prolapse in order to reposition them in their original location. Some pessaries are specifically designed to stabilize the urethra in cases of stress urinary incontinence (loss of urine when coughing, laughing or intense exercise, certain types of pessary require the patient to remove it at night or when the patient has sex.
  • Manufacturer
    Coopersurgical Inc

Manufacturer

Coopersurgical Inc