Events

Notificaciones De Seguridad De Campo acerca de 048.600 RN synOcta Abutment H2.5mm

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por INSTITUT STRAUMANN.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2014-01-07
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/07/01/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-abutment-tip-rn-synocta-cementable-rn-synocta-angled-rn-synocta-screw-retained-wn-synocta-screw-retained-wn-synocta-cementable-wn/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    Examination of one customer's complaint confirmed that the entire lot of 240 units 048.600 rn synocta abutment h2.5mm lot gj 235 contained information that incorrectly stated 048.612 lot gj040. the survey also confirmed that the aforementioned mistake is limited to this lot only. 91 pieces were distributed to clients maximum. package contains correct abutment 048.600 rn synocta abutment h2.5 mm lot gj235. our risk analysis has shown that incorrect labeling for patients on the packaging will not result in injury or illness to the patient. an incorrect tag is only registered as an error in the documentation in the patient's history file. the consequence of such an error in the documentation is the loss of trace in the event of future actions in the field, related to item 048.600 of gj235.

Device

048.600 RN synOcta Abutment H2.5mm

Manufacturer

INSTITUT STRAUMANN