Alerte De Sécurité sur Copper T380A intra-uterine contraceptive device (IUCD)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par manufacturer #13850.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2005-12-24
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    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

  • Modèle / numéro de série
  • Description du dispositif
    Press release: Update on Removal of Contraceptive Device
  • Manufacturer

Manufacturer