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, 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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
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It was reported an animal underwent an unknown veterinary procedure in (b)(6) 2024 and suture was used.During the veterinary procedure, the needle broke in the middle and part of it was in the dog's abdomen.As a consequences, the operation time was extended by opening up the abdomen to remove the needle.No adverse patient consequences were reported.Additional information was requested.
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