Events

Alerta De Seguridad para Copper T380A 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
    2005-12-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20051224.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
    Removal of contraceptive device 24 december 2005 (tuesday) the department of health (dh) had contacted all the 261 women using a same batch of copper t380a intra-uterine contraceptive device (iucd) which reported to have five incidents of breakage and expulsion in the past 12 months. a dh spokesman said: "out of the 261 clients contacted, 51 of them have the iucds removed at dh's maternity and child care centre. all the iucd were found intact." "dh's follow-ups also revealed no report of pregnancy arising from the breakage of iucd had been received." dh's hotline had received a total of 204 enquiries. the family planning association of hong kong's (fpahk) have sent out letters to all their clients and so far none reported being pregnant. a total of 59 clients have their iucds removed by fpahk. two of these iucds were found to be broken on removal. a total of 1161 pieces of the same batch of the affected iucds were used by dh's family health services and the family planning association of hong kong (fpahk) between 2001 and 2003. in view of the rising incidence of breakage reports, dh decided to remove the iucds from the clients as a precautionary measure. the spokesman stressed that 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 . the spokesman reminded women inserted with all models of iucd to attend checkups regularly.

Device

Copper T380A intra-uterine contraceptive device (IUCD)
  • Modelo / Serial
  • Descripción del producto
    Press release: Update on Removal of Contraceptive Device
  • Manufacturer
    manufacturer #13850

Manufacturer

manufacturer #13850