Events

Alerta De Seguridad para PHYSIOMESH Flexible Composite Mesh

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

¿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
    2016-05-31
  • Fecha de publicación del evento
    2016-05-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160531c.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: ethicon physiomesh flexible composite mesh medical device manufacturer, ethicon, has issued a medical device safety alert concerning its physiomesh flexible composite mesh [all product codes]. the manufacturer has initiated a worldwide medical device removal of ethicon physiomesh flexible composite mesh (for laparoscopic use). the manufacturer is removing the product following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/ reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh flexible composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. based on the currently available data, the manufacturer believes that the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but the manufacturer have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to remove ethicon physiomesh composite mesh from the global market. health care practitioners that have treated patients using ethicon physiomesh composite mesh are advised to follow those patients in the usual manner. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 may 2016.

Device

PHYSIOMESH Flexible Composite Mesh
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon PHYSIOMESH Flexible Composite Mesh
  • Manufacturer
    Ethicon

Manufacturer

Ethicon