Product complaint # (b)(4).H6.Component code: g07002 - device not returned.H 6.Investigation findings: c22 ¿ photo investigation.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Photo investigation summary : this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows an open box and ten packs of the 1961 product.Analysis of the photo showed multiple discrepancies in the labeling, such as the writing style and font of the product illustration did not match the information in the file.The ethicon raritan team performed further analysis to determine if the complaint represented a suspected product.According to the results, the device was consistent in construction with surgicel.The device was consistent with surgicel by ftir.However, the device is recycled and/or expired surgicel fibrillar.No suitable control 1961 product for box (lab001168v3, (b)(6)), but box is counterfeit for missing certain features.No suitable control 1961 product for package (lab001170v4), but package is counterfeit because of several visible errors.Based on the investigation performed, it was determined that the product is counterfeit, diversion was confirmed.Ethicon products were not distributed by authorized affiliates.A manufacturing record evaluation could not be completed as pty9723 batch is invalid.Event related to mw # 2210968-2024-01528, mw # 2210968-2024-01529, mw # 2210968-2024-01530, mw # 2210968-2024-01531.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.
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