Events

Alerta De Seguridad para Copper T 380A intra-uterine contraceptive device (IUCD)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por manufacturer #13850.

¿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
    2006-01-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20060118.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Press release
  • Causa
    Dh notified of intra-uterine contraceptive device cases 18 january 2006 (wednesday) in response to media enquiries, a spokesman for the department of health confirmed that the department has received notification from family planning association of hong kong (fpahk) that it was calling back all clients inserted with copper t 380a intra-uterine contraceptive device (iucd) for removal with or without replacement with another type of iucd. the association observed two cases of partially broken copper t 380a iucd of batch number 60401 and decided to call back all patients concerned as precautionary measure because broken iucd could lead to reduced contraceptive efficacy. the spokesman said that dh has alerted hospital authority, private hospitals, professional associations and medical practitioners of the incident of breakage of the batch of iucds . so far, no serious injuries related to breakage of these iucds have been reported locally or overseas. the spokesman said that dh did not use copper t 380a iucd of this batch. he called on women with iucds inserted should consult their doctors for advice. “if they suspect that they are pregnant or have symptoms of abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge, they should consult their doctors immediately,” he said.

Device

Copper T 380A intra-uterine contraceptive device (IUCD)
  • Modelo / Serial
  • Descripción del producto
    Press release: DH notified of intra-uterine contraceptive device cases
  • Manufacturer
    manufacturer #13850

Manufacturer

manufacturer #13850