(b)(4).Date sent to the fda: 10/20/2020 corrected h6 patient code: 2645 corrected information: b1, h1 ¿ it was reported that this device is not malfunction reportable.Therefore, this medwatch report 2210968-2020-07379 is not reportable.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.
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