(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned samples.Visual analysis of the returned samples revealed that one unopened sample that pertained to product code: (b)(4) was received.The sample was visually inspected and compared with the graphics within the internal system, product code (b)(4) and lot: v2002.Upon visual inspection, multiple discrepancies were identified on the labeling, for example missing barcode, incorrect artwork version, incorrect manufacturing, and expiration dates.In addition, the product artwork writing style and font type did not match the information on file.Based on the samples received, the product is confirmed to be counterfeit due to the discrepancies found in the labeling and packaging material.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Counterfeit product hence dhr not performed.
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