Copper T 380A IUCD 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medico Techno Pte Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2005-12-13
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Press release
  • 원인
    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

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Removal of Contraceptive Device
  • Manufacturer

Manufacturer