Product complaint # (b)(4).Date sent to the fda: 3/19/2024.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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: (b)(4).: during suture of the left tonsil store, two needles were released entirely from the threads inside the mucosa and muscle plane.(b)(4).: the same happened in 3 moments with a colleague during suture.Please provide an answer for each case: - was there any adverse consequence associated with the patient? - could you please advise if the 3 moments (pull off suture needle) happen during the same surgery? - please provide the lot number: - device return status.Please document the shipment tracking number: - please provide the source or name of person providing answers to follow-up questions: 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.Related reports: 2210968-2024-03187, 2210968-2024-03188, & 2210968-2024-03189.
|