Alerta De Seguridad para Trade Name: Surgical Network - PROCEED Commercial Model. N. Anvisa Reg.: 80145900785

Safety alert

826

2006-01-20

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Johnson & johnson products professionals ltd. reported that ethicon inc., a manufacturer of the surgical mesh product - proceed, found that an unacceptable level of delamination may have occurred in batches of this product, manufactured after august 1, 2005. in brazil, there is registration of import and distribution of batches affected by johnson & johnson professional products. the potential health hazard due to delamination from the product to be collected may result in exposure to polypropylene, which may cause potential adhesions and fistulas. the affected lots can be checked in annex i at the following electronic address: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2006/826.Pdf.

Ethicon Inc. of the United States is performing voluntary recall of specified lots and available on the international market. In Brazil, Johnson & Johnson Produtos Profissionais Ltda. Notified Anvisa of the incident and informed that the company has already started the collection process with its customers and distributors. The company further informs that according to Johnson & Johnson's internal traceability system all customers have already been identified and the recall notice has already been forwarded to all of them. The company points out that the distribution or use of affected lots should cease immediately. UPDATE OF INFORMATION (05/29/2006) AFFECTED PRODUCT UNITS ARE DUE RECEIVED AND REPLACED IN THE JOHNSON & JOHNSON LOGISTICS DISTRIBUTOR AREA. JOHNSON & JOHNSON IS WAITING FOR CONFIRMATION OF FINAL DISPOSAL BY MANUFACTURER ETHICON INC. (US), HOW MUCH THE INUTILIZATION OF THE REFERRED PRODUCTS, AND SHALL INFORM THE LOGISTICAL DEALER OF THE REQUIRED SHARES. IN ACCORDANCE WITH J & J; TAKING AS BASIC CAUSE - ROOT OF THE PROBLEM, MEASURES ARE BEING PROPOSED BY THE ETHICON, INC. (USA) MANUFACTURER TO COMPLY WITH QUALITY DEVIATIONS. THESE MEASURES MAY INCLUDE THE FOLLOWING ACTIONS: • CHANGES IN THE PACKING SPECIFICATION; • CHANGE IN THE SPECIFIC STAGE OF THE MANUFACTURING PROCESS; • INCLUSION OF ADDITIONAL TESTS ON THE FINISHED PRODUCT; • CHANGE IN THE RAW MATERIAL SPECIFICATION USED IN THE PROCESS; • UPDATES OF WORK INSTITUTIONS AS TO TIME OF EXTRUSION, LAMINATION AND CUTTING STAGES DURING THE MANUFACTURING PROCESS. THE COMMERCIAL OPERATIONS WITH THE PRODUCT, BOTH DISTRIBUTION AND SALES, ARE MOMENTALLY SUSPENDED IN BRAZIL AND THE UNITED STATES, THE PRODUCT RELATING IN THE USA IS PLANNED BY JULY OF THE CURRENT YEAR, AFTER APPROVAL OF THE CORRECTIVE ACTIONS PRESENTED TO THE FDA AND CONSEQUENTIAL IMPLEMENTATION.