Events

Alerta De Seguridad para Name of Endodontic Resuscitation Name: Disposable Blades ANVISA Registration Number: 80804050138 Hazard Class: II Affected Model: 7205305 - Endoscopic Resuscitation FULL RADIUS 3.5mm Straight Beige Serial Numbers Affected: 50983335, 50983334, 50977889, 50975556, 50970649, 50968791, 50964650, 50961735 and 50952320.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. - Endoscopic Division.

¿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
    2175
  • Fecha
    2017-02-08
  • 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
    1. Locate and immediately quarantine the unused affected devices. 2. Return the quarantined product to Smith & Nephew's national agency or distributor. 3. Fill out the return form and send it by email to the Smith & Nephew national distributor. 4. Ensure that this safety information is passed on to all who need to be aware of it within your institution. 5. Observe this notice, as well as the resulting action, until the corrective security action is completed to ensure its effectiveness.
  • Causa
    Smith & nephew, inc. has initiated a field correction for several batches of full radius ™ blade 3.5mm due to a manufacturing error. the product was produced with a black ultem blade insert, instead of blue polycarbonate.
  • Acción
    Field Action Code 001/2017 triggered under the responsibility of Smith & Nephew Comércio de Produtos Médicos Ltda. Company will collect.

Device

Name of Endodontic Resuscitation Name: Disposable Blades ANVISA Registration Number: 80804050138 ...

Manufacturer

Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. - Endoscopic Division