Events

Alerta De Seguridad para neuron max catheters

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

¿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
    2013-10-28
  • Fecha de publicación del evento
    2013-10-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131028.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: penumbra neuron max catheters medical device manufacturer, penumbra inc., has issued a medical device safety alert concerning neuron max catheters. the affected catalogue numbers are as follows: pnmd8f088804m - 8f 088 neuron max 088 delivery catheter 80/4 mp pnmd8f088904m - 8f 088 neuron max 088 delivery catheter 90/4 mp pnml6f088804m - 6f 088 neuron max long sheath 80/4 mp pnml6f088904m - 6f 088 neuron max long sheath 90/4 mp pnml6f0881004m - 6f 088 neuron max long sheath 100/4 mp the manufacturer has recently identified that, for some neuron max catheters, it is possible for the packaging mandrel to remain within the catheter during removal. when this occurs, the catheter tip can be damaged. this is due to reduced adherence of the mandrel to the packaging card. the manufacturer advises affected users to take the following preventive actions: follow the product instructions for use and remove the device carefully inspect the device prior use to detect any damage has occurred to the product during the removal from the packaging. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2013.

Device

neuron max catheters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Penumbra Neuron MAX Catheters
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.