Events

Alerta De Seguridad para Cofferam Templates, Frames, Punches, Removal Plugs Coferam Rings

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Dentech Corporation, Japan.

¿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
    1
  • Fecha
    2017-05-09
  • 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
    Labels are made by dentech corporation (japan). checking the information in the european database of medical devices eudamed revealed that this manufacturer's registration was terminated in 2009. (does not correspond to point 43 of the regulation); the label states that the authorized representative of the japanese manufacturer dentech corporation is the uk company four d rubber co. limited. four d rubber co., eudamed, the european database for medical devices. linited is registered as an authorized representative, but its list of manufacturers does not include the japanese manufacturer dentech corporation (does not meet point 45 of the regulation); conditions for the storage and / or maintenance of a non-specified medical device (for example, no indication of the means to be used for cleaning, disinfecting the medical device) (not in accordance with annex 1, point 14.3.9 of the regulation); the batch number on the drum punch label does not match the batch number on the medical device. medical devices do not bear the ce conformity marking (not in compliance with points 38 and 39 of the regulation); no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with annex 1, paragraph 14.3.1 of the regulation); batch / serial number not specified (not in compliance with annex 1, point 14.3.4 of the regulation); conditions for the storage and / or care of a non-specified medical device (for example, no indication of the means to be used for cleaning, disinfecting the medical device) (not in accordance with annex 1, point 14.3.9 of the regulation).
  • Acción
    Do not allow to enter the Lithuanian market

Device

Cofferam Templates, Frames, Punches, Removal Plugs Coferam Rings

Manufacturer

Dentech Corporation, Japan
  • Empresa matriz del fabricante (2017)
    Dentech Corporation
  • Representante del fabricante
    UAB Astravita
  • Source
    MH