Alerta De Seguridad para Copper T 380A IUCD

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medico Techno Pte Ltd..

¿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
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Removal of contraceptive device 13 december 2005 (tuesday) the department of health (dh) has received five reports of breakage and expulsion of a batch of intra-uterine contraceptive device (iucd) in the past 12 months and women using such devices will be contacted for follow-up. as the contraceptive effect may be affected, dh and the family planning association of hong kong (fpahk) will contact the concerned women for checkups including the removal and replacement of iucd if necessary. a total of 1161 pieces of the iucd, of model copper t 380a and batch number fd 010201, had been used by dh's family health services and fpahk between 2001 and 2003. the supplier of the affected device was medico techno pte ltd. of singapore . a dh spokesman said the replacement is a precautionary measure as there has not been any report of major side effect related to using the affected iucd so far. "in the past 12 months, fpahk has reported a total of 5 cases of the device found broken and being partially or completely expelled from the uterus. no similar occurrence has been noted in dh's clients. "broken and expelled iucd will obviously affect contraceptive effect. women inserted with iucd should immediately consult their doctors and take other contraceptive measures if the iucds are found expelled." "using iucd is a very effective and safe method of contraception. it carries uncommon complications such as expulsion and pelvic infection. women inserted with iucd should immediately consult their doctors if they suspect to be pregnant, or have abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge ," he added. the spokesman reminded women inserted with all models of iucd to attend checkups regularly. dh and fpahk are taking steps to contact their clients for follow-up. dh has set up telephone hotlines 2961 8839 and 2961 8740 to answer public enquiries on the matter. the hotlines will operate until 9 pm today and during office hours from tomorrow. the hotline of fpahk is 2919 7725.


  • Modelo / Serial
  • Descripción del producto
    Press release: Removal of Contraceptive Device
  • Manufacturer