Safety Alert for PATCH ORGANIC BIOMEND, models BIOMEND and BIOMEND EXTEND (Anvisa Registry: 10355870093. Affected lots: 1105175, 1111859 and 1104847 (Biomend Extend); 1111358 and 1111865 (Biomend). ) Affected lots: 1110239 (Colla Plug), 1111644 (Colla Cote) and 1112262 (Colla Tape, see details in the attachment http://portal.anvisa.gov.br/wps/wcm/connect/e73bf38040357a1cb017f0dc5a12ff52/Alerta_Biomend.pdf? MOD = AJPERES

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.

During the internal quality assurance review of the company's processes, the manufacturer of the product found that there may have been a deviation of a production process during the manufacture of specific batches of the product. All batches in question have been subjected to final final product release tests, are sterile and have been tested and accepted for endotoxin level. However, due to a deviation in the process, they may have been released with higher levels of endotoxin than allowed by the product specifications. High levels of endotoxin may result in fever in the immediate postoperative period. However, neither the manufacturer nor Biomédica (who owns the product registration in Brazil) received reports or complaints regarding patient injuries or other adverse events related to these batches of products possibly affected. According to Biomedica, communication to affected customers will be made via e-mail or letter to buyers of the product.