Events

Alerte De Sécurité sur Copper T 380A 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 Medico Techno Pte Ltd..

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
    2005-12-13
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20051213.html
  • 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 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.

Device

Copper T 380A IUCD
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Removal of Contraceptive Device
  • Manufacturer
    Medico Techno Pte Ltd.

Manufacturer

Medico Techno Pte Ltd.