Events

Alerta De Seguridad para BIOMATRIX FLEX CORONARY STREAM SYSTEM WITH DRUG ELIMINATION - Registration: 80102510990 - Risk Class: IV (Maximum Risk) - Models Affected: BMX3511; BMX3518; BMX3524; BMX4024; BMX4024 - Lots Affected: 35 BMX- 4018 LOT K15100017 NOT COMMERCIALIZED

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; BIOSENSORS EUROPE AS.

¿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
    1873
  • Fecha
    2016-04-12
  • 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
    The affected product was not marketed, was in company stock and will be returned to the manufacturer. Patients who have already received the implant of an affected device are not compromised by this safety correction action. There were no complaints or injuries of patients associated with the compromised performance of the balloon.
  • Causa
    During routine batch testing, biosensors found that some production batches did not meet balloon rupture performance specifications. after an investigation, biosensors concluded that the balloon's compromised performance was triggered by specific characteristics in the manufacturing process. biosensors identified production lots manufactured between october and december 2015, which may have been similarly affected.
  • Acción
    All products imported from the affected batch were in stock and will be returned to the manufacturer. Code 001/2016

Device

BIOMATRIX FLEX CORONARY STREAM SYSTEM WITH DRUG ELIMINATION - Registration: 80102510990 - Risk Cl...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; BIOSENSORS EUROPE AS
  • Source
    ANVSANVISA