Events

Safety Alert for Commercial Name: Upic Monitoring System Ventura /// Technical Name: Monitoring Kit /// ANVISA Registration Number: 10175060024 /// Hazard Class: IV - Maximum Risk /// Model Affected: 06029403- Drain Catheter Assembly External and / or monitoring of ventricular PIC -6F; 06029404 - External Drainage catheter assembly and / or PIC 9F monitoring Parenchymatous /// Affected lot numbers: See Distribution map

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ventura Biomédica Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1987
  • Date
    2016-08-31
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Discontinue use, segregate affected products and return them to the manufacturer.
  • Reason
    Product is being marketed in disagreement with its registration with anvisa.
  • Action
    Field Action Code 216/2016 triggered under the responsibility of Ventura Biomédica Ltda. Company is performing recall of the affected products.

Device

Commercial Name: Upic Monitoring System Ventura /// Technical Name: Monitoring Kit /// ANVISA Reg...

Manufacturer

Ventura Biomédica Ltda.