Events

Alerta De Seguridad para EXTRACT OF SURGICAL CLAMPS PROXIMATE * - Record 10132590054 - Lots Affected - See annex .. http://portal.anvisa.gov.br/wps/wcm/connect/19c0fb004d632634b56bf5c116238c3b/Lotes_Afetados.pdf?MOD=AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda..

¿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
  • ID del evento
    1197
  • Fecha
    2012-11-09
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Ethicon Endo-Surgery has initiated a voluntary recall of all PSX Proximate® Skin Staple Extractors products because of the possibility that damage to the packaging may have compromised the sterility of the product. The problem was detected internally during the packaging process. No customer complaints related to this issue were received, as well as no adverse event reports associated with the product under recall. Ethicon Endo-Surgery has stopped production and shipment of the affected product and is investigating the root cause of the packaging problem and will implement actions to resume production. There are no notifications to date in the NOTIVISA system. Anvisa follows this action.
  • Causa
    Possibility of compromising the sterile barrier of the package.
  • Acción
    Users are advised to: See annex. http://portal.anvisa.gov.br/wps/wcm/connect/35191e004d6326a7b574f5c116238c3b/Carta_aos_Hospitais.pdf?MOD=AJPERES 1. Inspect your inventory immediately to see if you have the affected product, and separate those products. View detailed images to help identify affected products. 2. Fill out the Business Response Form and fax it to (11) 3030-1109 or return it to your local sales representative within 3 business days of receiving this notice, even if you do not have the product affected. Mention Event 5928. If you have any product to be returned, keep a copy of this form in your records. 3. To return the affected product, take a xerox copy of the completed Business Response Form, place it in the box along with your product, and attach the pre-printed shipping label and mail it to the company's local warehouse. 4. Share this information with all appropriate personnel in your facility. 5. As for any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.

Device

EXTRACT OF SURGICAL CLAMPS PROXIMATE * - Record 10132590054 - Lots Affected - See annex .. http:/...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.