Events

Alerta De Seguridad para 3M Universal Electrosurgical Pads

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por 3M.

¿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
    2017-03-20
  • Fecha de publicación del evento
    2017-03-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170320a.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: 3m universal electrosurgical pads boston scientific has issued a medical device safety alert concerning 3m universal electrosurgical pads [sku: sgp-082-100, sgp-080-40; lot number: 2019-02dt, 2019-03du, 2019-02db; expiration date range: 1 feb 2019 to 1 mar 2019], manufactured by 3m. this recall follows confirmation of a single user report of an unintended material (process liner) in the product. the presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site. this removal affects only the lots listed in this notification. further distribution or use of any remaining product affected by this action should cease immediately. according to the local supplier (boston scientific), the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 march 2017.

Device

3M Universal Electrosurgical Pads
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: 3M Universal Electrosurgical Pads
  • Manufacturer
    3M

Manufacturer

3M