Events

Recall of Mona Lisa CuT 380A QL

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by HRA Pharma.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2009-02-20
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lot-de-dispositif-medical-intra-uterin-mona-lisa-cut-380a-ql-hra-pharma
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    On 19/02/09, the company HRA Pharma withdrew from the market lot 2007E04A (expiry 05/2011) of the intrauterine medical device Mona Lisa CuT 380A QL following claims describing, due to a manufacturing defect, the impossible passage of the intra-uterine device through the insertion tube, thus preventing its insertion in the patient. The users concerned were informed by the laboratory, directly from the attached messages (20/02/2009) (96 ko ) or by general distribution to wholesalers / pharmacies and pharmacies of health establishments (20/02/2009) (97 KB). This information is addressed to the directors and correspondents of materiovigilance of the health establishments for diffusion if necessary to the services concerned, to the gynecologists of town, to the centers of maternal and infant protection and to the general councils concerned, to the wholesale distributors and pharmacists of town.

Device

Mona Lisa CuT 380A QL
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    HRA Pharma

Manufacturer

HRA Pharma
  • Manufacturer Parent Company (2017)
    HRA Pharma
  • Source
    LAANSM