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.Attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained via: it was reported that "needles tear off the suture".Please confirm the number of needles that tear off the suture during this procedure.5 ea from 36 package (1 sales unit) we will sent 31 back.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: mwr-10032024-0001590587, mwr-10032024-0001590588, mwr-27032024-0001602177, mwr-27032024-0001602178, mwr-27032024-0001602179.
|