Events

Alerta De Seguridad para Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Neoss.

¿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
  • Fecha
    2015-09-23
  • Fecha de publicación del evento
    2015-09-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923c.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: neoss guide – drill-hubs i to v included in neoss guide kit the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning neoss guide – drill-hubs i to v included in neoss guide kit ø3.5 - ø4.5 (art number 51153), manufactured by neoss. the affected product identifier is 9040, with product numbers (bn) 15182, 15586 and 16030. according to the alert, the affected batches of drill-hub i may not be functioning as intended. specifically, the drill does not latch completely in the drill-hub i. the upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended, this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected. the manufacturer advises affected users to inspect their stock on hand and to quarantine affected units prior to their return to the manufacturer. for details, please refer to the tga websites:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00917-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit
  • Manufacturer
    Neoss

Manufacturer

Neoss