(b)(4).Date sent: 3/4/2024.Additional information was requested and the following was obtained: "surgeon was highly concerned patient may be allergic to clips." 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: "what was the initial procedure? what is surgeons experience with this device? what is the exact product code of the device/clips used? has the patient been previously diagnosed with a metal allergy?" 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.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, 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.
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