(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.H6 component code: g07002 - device not returned.To date the device has not been returned.If the device or further details are received later a supplemental medwatch will be sent.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.The following information was requested, but unavailable: - please provide the product code and lot number? --- after several months from complaint creation, it's difficult to retrieve this data.Info not available.
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It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During surgery, the needle detaches from the suture because after few steps the needle tip gets blunt, and the needle remains in the hands of the operator.No adverse patient consequences were reported.Additional information was requested.
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