Events

Safety Alert for Catheter for measurement of tissue oximetry LICOX., Class IV, Model: CC1. P1. Record: 10099430125. Serial number: 260614 (in stock in the company).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DABASONS Importação Exportação e Comércio Ltda.; GMS Gesellschaft für Medizinische Sondentechnik mbH.

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
    1520
  • Date
    2014-11-11
  • 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
    The importing company clarified that the product will be collected and forwarded to the manufacturer. There was no report of patient harm or adverse health effects associated with this complaint. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    The company integra lifesciences has identified that there is a possibility that the pbto² readings may be underestimated due to an improperly programmed smart card when using one of the catheters.
  • Action
    The company holding the record explained that of the affected products, it had imported only one lot, all were still in the company's stock and, so far, we had not marketed any units. Fifteen units were imported and they were segregated and later returned to the manufacturer.

Device

Catheter for measurement of tissue oximetry LICOX., Class IV, Model: CC1. P1. Record: 10099430125...

Manufacturer

DABASONS Importação Exportação e Comércio Ltda.; GMS Gesellschaft für Medizinische Sondentechnik...
  • Source
    ANVSANVISA