(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.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: please provide the original purchase order: can you please provide the invoice? are there any pictures available? what is the carrier associated with the delivery? if available, what is the container lp number (lp: license plate associated with the shipment)? there is no picture available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2022-08486, 2210968-2022-08488 and 2210968-2022-08489.
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