Events

Safety Alert for MEDRAD Syringe for Contrast Injection Registration: 80172890031, lots 172003; 172005.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDRAD do Brasil.; Medrad Inc.

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
    1594
  • Date
    2015-05-18
  • 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
    This action does not indicate malfunction of the syringe. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client and change of the product registration to include a new alert of the interference with Fulvestrant.
  • Reason
    Nationalization tag error. in the syringe label is labeled model sqk65vs being the correct ssqk / 115vs.
  • Action
    The company that holds the record will collect the product and advise customers to have the syringes in stock, discontinue use and contact the company.

Device

MEDRAD Syringe for Contrast Injection Registration: 80172890031, lots 172003; 172005.

Manufacturer

MEDRAD do Brasil.; Medrad Inc
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    ANVSANVISA