Events

Alerta De Seguridad para L-Gel Ultrasound Transmission Gel

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

¿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
    2012-08-17
  • Fecha de publicación del evento
    2012-08-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120817.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: shanghai shenfeng l-gel ultrasound transmission gel the australia therapeutic goods administration (tga) has issued a recall of all lots of l-gel ultrasound transmission gel manufactured between june 2011 and may 2012 by shanghai shenfeng, china. the gel is supplied in 250ml and 5l bottles. the recall was initiated after tga tests found bacterial contamination (burkholderia cepacia, stenotrophomonas maltophilia and raoultella planticolla) in lot numbers 2011 06 17 to 2012 04 09 of the product. there is a small risk that patients who have been exposed to contaminated l-gel ultrasound transmission gel may develop an infection, this infection will usually be in the area where the gel was used. stop using l-gel ultrasound transmission gel products with lot numbers 2011 06 17 to 2012 04 09. identify patients who have been exposed to these lots of l-gel ultrasound transmission gel. review the procedures they underwent and the outcomes of the procedures, and take further action as necessary. for details, please refer to tga website: http://www.Tga.Gov.Au/safety/alerts-device-l-gel-120816.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 august 2012.

Device

L-Gel Ultrasound Transmission Gel
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Shanghai Shenfeng L-Gel Ultrasound Transmission Gel
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH