Events

Alerta De Seguridad para Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L (3D-23G-90mm), COG PDO Tread Blunt (3DB19G-100mm), 3D COG Thread Sharp (3D-22G70mm)

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Not specified.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    6
  • Fecha
    2017-11-24
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The medical devices are marked with two ce conformity marks with the number of the notified bodies 1282 and 0197. in accordance with the provisions of the regulation, the ce marking must be accompanied by the identification number of one of the notified bodies responsible for applying the procedures set out in the annexes to this regulation. in addition, the ce mark does not conform to the form set out in annex 12 to the regulation. such marking does not comply with the requirements of articles 38-40 of the regulation; instructions for use have not been added to medical devices as required by annex 1, paragraph 14.1 of the regulation; medical devices do not include the name and address of the manufacturer and the authorized representative within the european union and its address as required by annex 1, paragraph 14.3.1 of the regulation.
  • Acción
    Not allowed to enter the Lithuanian market

Device

Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L ...

Manufacturer

Not specified
  • Representante del fabricante
    UAB Urmo Group
  • Source
    MH