Events

Safety Alert for Copper T 380A intra-uterine contraceptive device (IUCD)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by manufacturer #13850.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2006-01-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20060118.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Press release
  • Reason
    Dh notified of intra-uterine contraceptive device cases 18 january 2006 (wednesday) in response to media enquiries, a spokesman for the department of health confirmed that the department has received notification from family planning association of hong kong (fpahk) that it was calling back all clients inserted with copper t 380a intra-uterine contraceptive device (iucd) for removal with or without replacement with another type of iucd. the association observed two cases of partially broken copper t 380a iucd of batch number 60401 and decided to call back all patients concerned as precautionary measure because broken iucd could lead to reduced contraceptive efficacy. the spokesman said that dh has alerted hospital authority, private hospitals, professional associations and medical practitioners of the incident of breakage of the batch of iucds . so far, no serious injuries related to breakage of these iucds have been reported locally or overseas. the spokesman said that dh did not use copper t 380a iucd of this batch. he called on women with iucds inserted should consult their doctors for advice. “if they suspect that they are pregnant or have symptoms of abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge, they should consult their doctors immediately,” he said.

Device

Copper T 380A intra-uterine contraceptive device (IUCD)
  • Model / Serial
  • Product Description
    Press release: DH notified of intra-uterine contraceptive device cases
  • Manufacturer
    manufacturer #13850

Manufacturer

manufacturer #13850