Events

Alerta De Seguridad para Donor chairs

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Mobile Designs Inc., USA.

¿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
    2
  • Fecha
    2017-04-20
  • 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
    Medical devices do not bear the ce conformity marking (not in compliance with the requirement of article 38 of the regulation); there is no information on the manufacturer's authorized representative in the european economic area on the label and in the instructions for use of the medical device (does not meet the requirements of annex 1, paragraphs 14.3.1 and 14.6.1 of the regulation); batch / serial number not indicated on the label of the medical device (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); conditions for the storage and / or maintenance of a medical device not mentioned in the label and instructions for use of the medical device (for example, it does not specify the means to be cleaned and disinfected by these chairs) (does not comply with point 14.3.9 of annex 1 to the regulation); after checking the eu database of medical devices eudamed and the lithuanian medical devices information system mepris, no information was found about the mobile folding blood donor seats md 2500 and their manufacturer mobile designs inc., usa.
  • Acción
    Not allowed to enter the Lithuanian market

Device

Donor chairs

Manufacturer

Mobile Designs Inc., USA
  • Representante del fabricante
    UAB ABT Baltic
  • Source
    MH