Alerte De Sécurité sur PROLENE * mesh / polypropylene mesh, code PMII, with lots numbers RBE609 (due date July 1st) and RJJ130 (due date July 07)

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.

PROLENE is a non-absorbable mesh / mesh used for the repair of hernias and other fascia deficiencies, which require the addition of a reinforcing material or to build bridges in order to achieve the desired surgical result. Doctors, nurses, and all other health care professionals should carefully examine all PROLENE (3 'x 6') screen products before use. The counterfeit product differs from the authentic PROLENE screen, where the counterfeit product may display the following: - There is a seal on the packaging that does not tear gently when opening (tamper evident seal). - There is also a small additional seal on the corner edges at the top of the package; - There is one end in the fabric that is uneven, and not a straight cut (finish) on the 3-inch side; - The ETHICON company logo appears with a crude impression, escaping from the original standard. ETHICON is working with the FDA to investigate this issue and prevent further distribution of the counterfeit product. ETHICON became aware of the distribution of the counterfeit product in the US only on October 24. Disclose this information to your personnel and anyone else who uses the PROLENE screen so that you are able to identify the characteristics of the counterfeit product. The counterfeit product could have entered through the dealer network. So if you have and your stock any product under suspicion, do not use. Place the quarantine, ensuring that it is not used, and later, contact the Technovigilance Unit through the electronic address: http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.aspou by phone : 61-4481331 or fax: 61-4481257.