Events

Alerta De Seguridad para Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dressing, Curity Sodium Chloride Dressing and Curity Saline Dressing

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

¿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
    2017-03-08
  • Fecha de publicación del evento
    2016-12-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170308a.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: medtronic covidien curity eye pad, curity eye pad oval, curity wet dressing, kerlix super sponge saline dressing, curity sodium chloride dressing and curity saline dressing medical device manufacturer, medtronic, has issued a medical device safety alert concerning its eye gauzes. details of the affected products as below:- a) covidien curity eye pad; b) covidien curity eye pad oval; c) covidien curity eye pad; d) covidien curity wet dressing; e) covidien kerlix super sponge saline dressing; f) covidien curity sodium chloride dressing; g) covidien curity saline dressing item code: a) 03201; b) 2841; c) 91650; d) 3337; e) 3338; f) 3339; g) 3606 lot numbers beginning with: a–c) 12, 13, 14, 15, 16; d–g) 14, 15, 16 (exclude lots 16j098062, 16j098162, 16j098262) expiration date: a–c) from feb 2017 through nov 2021; d–g) from feb 2017 through nov 2019 this voluntary recall is being conducted due to the potential for the sterile packaging to be compromised. according to the manufacturer, the use of products with this condition may result in a potentially increased risk for infection. the customers are requested to quarantine and return any unused products of the affected items and lots. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 december 2016.

Device

Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dre...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dressing, Curity Sodium Chloride Dressing and Curity Saline Dressing
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH