Alerta De Seguridad para Standard Rigid Tip Suction Wand

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

¿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
    2012-11-07
  • Fecha de publicación del evento
    2012-11-07
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: california medical laboratories standard rigid tip suction wand medical device manufacturer, california medical laboratories, inc. has initiated a field safety corrective action concerning the standard rigid tip suction wand (item no.: su-12202, lot no.: s111480 and s112462). due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. this would likely be identified during, or prior to, the procedure. if the issue goes unnoticed there is the possibility of risk to the patient should the clinician not remove the detached component and subsequently close the surgical site. the manufacturer is notifying the affected users not to use the affected products and to return any unused product and order replacements. according to conmed limited, the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 november 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: California Medical Laboratories Standard Rigid Tip Suction Wand
  • Manufacturer

Manufacturer