Events

Safety Alert for Mona Lisa CuT 380A intra-uterine contraceptive device

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Mona Lisa N.V.

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
    2013-03-08
  • Event Date Posted
    2013-03-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130308a.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
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: mona lisa cut 380a intra-uterine contraceptive device it has come to our attention that there is a quality issue concerning intra-uterine contraceptive device manufactured by mona lisa n.V (model number: cut 380a, lot number: 2012-k-30). on 7 march 2013 morning, during random spot checking before product distribution to maternal and child health centres (mchcs), the family health service (fhs) of the department of health (dh) found that some products of the lot (2012-k-30) have black hair or thread-like substance within the sterile packaging. the affected products have not yet been distributed to the mchcs. according to the local supplier, cnw far east ltd., the affected lot has only been distributed to fhs of dh and it has not received similar complaints from other users. so far the local supplier has not received any information from the manufacturer about recall of the affected product. dh instructed the local supplier to recall the affected lot from the user. investigation is ongoing. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 march 2013.

Device

Mona Lisa CuT 380A intra-uterine contraceptive device
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Mona Lisa CuT 380A intra-uterine contraceptive device
  • Manufacturer
    Mona Lisa N.V

Manufacturer

Mona Lisa N.V