Events

Safety Alert for Homechoice for Peritoneal Dialysis. Anvisa Registry n ° 10068390123.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar 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
    1448
  • Date
    2014-10-24
  • 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
    Check additional information in the documents PATIENT LETTER and LETTER TO THE DIALISE CENTER, available respectively at: http://portal.anvisa.gov.br/wps/wcm/connect/1a469d8045fc3468a811ac7ffa9843d8/CARTA+AO+PACIENTE.pdf?MOD=AJPERES and http://portal.anvisa.gov.br/wps/wcm/connect/7681c28045fc337fa808ac7ffa9843d8/CARTA+AO+CENTRO+DE+DIALISE.pdf?MOD=AJPERES
  • Reason
    Some homechoice equipment was sent to customers without the addition to the manual.
  • Action
    Updating, correcting or supplementing the instructions for use.

Device

Homechoice for Peritoneal Dialysis. Anvisa Registry n ° 10068390123.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA