This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 45 patients had post-procedure complication after the procedure with the use of the device and before the discharge of the index admission was defined with the diagnosis code, bleeding.2 patients had post-procedure complication after the procedure with the use of the device and before the discharge of the index admission was defined with the diagnosis code, wound disruption.10 patients had post-procedure complication after the procedure with the use of the device and before the discharge of the index admission was defined with the diagnosis code, surgical site infection.
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Product complaint # (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.(b)(4).This report is related to data research, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.
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