It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.Before use on patient, it was reported that the devices wax oil leakage and customer complaint that the printing on the packaging was illegible.This issue was found during checking, not involved in any surgery.No adverse patient consequences were reported.No additional information was provided.
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Product complaint # (b)(4).Date sent to the fda: 02/09/2022.H6 component code: g07002 - device not returned.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.Photo analysis: visual analysis of the three images submitted for evaluation determined that a closed sample of product code w810t could be seen.Visual inspection concluded that the bone wax stick apparently melted in an open folder.As part of our quality process, the manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.No conclusion could be reached on the cause of the reported complaint as the sample was not returned for analysis.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.
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