Alerta De Seguridad para Negative Pressure Wound Therapy Pump Extricare 2400, Model EC2400-E, Registration 80047309100, Lot 41513 // Extricare 2400 Bandages, Models EC2400-LO-E; EC2400-SO-E; EC2400-SE; EC2400-HE; EC2400-MN-E; EC2400-IM-E; EC2400-FE, Registration 80047300462, lot 41523

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.

The various modes of failure of the ExtriCare and the complaints were presented to a panel of three independent external medical specialists (March 19, 2015, Herlev University Hospital, Copenhagen, Denmark) for the purpose of obtaining an external assessment of the related safety concerns with the use of ExtriCare. The experts confirmed the link between failure modes and risk for patients, based on their clinical experience and the literature. The malfunction of the ExtriCare NPWT system poses serious risks to patient safety in terms of localized infections, systemic infections (sepsis), and delayed wound healing.