Alerta De Seguridad para InterGard Knitted Silver IGK 1407S Prosthesis - Series 8260121 - Lot 02C29

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.

Brazil 04.08.2002- Existence of an affected product in Brazil. INTERVASCULAR - USA issued a notice of correction on September 2 to POLITEC IMPORT & TRADE LTDA-Brazil, requesting that it state whether the product was in stock or consigned in a hospital or if it had been implanted. ANVISA through the Technovigilance Unit contacted the representative in Brazil (POLITEC IMPORTAÇÃO E COMÉRCIO LTDA) and it informed that the said product was in stock and the blocking was provided, informing the manufacturer (INTERVASCULAR US ) of the action taken. On 20.09.2002, they received authorization from the manufacturer for the return of the product that was sent by DHL on 09.29.2002, closing the whole process.