Events

Safety Alert for PHONENIX HYDRAULIC DRAIN VALVE

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

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
    767
  • Date
    2004-04-15
  • 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
    It is of fundamental importance that healthcare professionals are aware of all the information advocated by the manufacturer, especially the instructions for use and possible side effects that may arise from the use of such products. If there is a need to notify any adverse event or quality deviation on this or any other health products (medical articles, orthoses and prosthetics, medical equipment and in-vitro diagnostic kits), please contact: ANVISA - AGENCY NATIONAL SANITARY SURVEILLANCE Unit of Technovigilância - UTVIG SEPN 515 - Block B - 4th. Andar - Sala 01 Asa Norte - Brasília - DF CEP .: 70.770-502 Tel .: (0xx61) 448 1331/448 1485 Fax .: (0xx61) 448 1257 e-mail: tecnovigilancia@anvisa.gov.br If you prefer, use the Notification of Special Technovigilance on the website: http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp
  • Reason
    The notified events report possible drainage, above or below, of the manufacturer's specifications. such events can be caused by quality deviations from some product units.
  • Action
    The Technovigilance Unit continues to investigate the notifications received from the product, and to date, nothing can be concluded regarding the probable or probable causes of the occurrence of the notified events. Conceptually and according to the international literature, it is worth remembering that the occurrence of adverse events with health products may possibly be attributed to misconceptions regarding the clinical procedures performed. In practice, any deviations in the indication, use, etc. can collaborate for the occurrence of such events, as previously reported.

Device

PHONENIX HYDRAULIC DRAIN VALVE

Manufacturer

PHOENIX BIOMEDICAL CORP
  • Source
    ANVSANVISA