Copper T380A intra-uterine contraceptive device (IUCD) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 manufacturer #13850 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
    2005-12-24
  • 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 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

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

Manufacturer