Product complaint (b)(4).Evaluation: product sample was not received.Analysis of four photos submitted for review.During the visual analysis the following was observed: the photographs show two damaged boxes of the bonewax product, packages out of the box were melted.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Note: events reported on mw# 2210968-2022-08139.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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