(b)(4).The following information was requested, but unavailable: - how was the product purchased? - is there an indication of how the product was distributed? - is there any indication of the source? - based on the packaging, is there any indication of which market the original genuine product may have come from? - was the device used on a patient? if so, was there any patient consequence? photo investigation summary: the packaging was observed to be according to the process specifications and the product was manufactured by ethicon, the diversion product is confirmed, since the ethicon product was not distributed by an authorized affiliate.Investigation summary: the product was returned for evaluation.In a further investigation of the samples received, it was observed that certain carton shading appeared to be missing as compared to approved carton artwork.The inside foil pouch appearance appears shinier than the approved material appearance.In addition, it was noted timestamp was identical for all packages of the same line.Based on the information currently available, the counterfeit was identified during the investigation of the samples received.Event related to mw # 2210968-2022-06652, mw # 2210968-2022-06656, mw # 2210968-2022-06688.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
|