Product complaint (b)(4).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.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm the number of sutures that pulled off during this procedure.Please provide the lot number of the sutures that pulled off.When did the needle detach/pull off from the suture (in the package, during removal from the package, during handling before use on patient)?if other, please specify please confirm the number of sutures that broke during this procedure.Please provide the lot number of the sutures that broke.When did the suture break (in the package, during removal from the package, during handling before use on the patient)? if other, please specify please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) events reported via: 2210968-2024-00456.
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