Safety Alert for INSULIN MINIMED MMT 508 INFUSION PUMP WITH REMOTE CONTROL. CATHETER APPLICATOR, BRAND SILHOUETTE

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOTEC COMERCIAL, IMPORTADORA E EXPORTADORA.

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
    91
  • Date
    2001-10-02
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    UNTIL THIS DATE, NO CLARIFICATION HAS BEEN FURTHER PROVIDED.
  • Reason
    Lack of registration in the ministry of health and absence of information regarding the process of the product.
  • Action
    INTERMISSION OF INSULIN INFUSION PUMP FOR MINIMED MMT 508 WITH REMOTE CONTROL FOR LACK OF REGISTRATION AND ABSENCE OF INFORMATION ABOUT THE SOURCE. THE BIOTEC DISTRIBUTOR COMPANY COMMERCIAL, IMPORTER AND EXPORTER, RESPONSIBLE FOR THE MARKETING OF THE PRODUCT, WAS PARTIALLY INTERVENED.

Manufacturer