This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing laparoscopic inguinal hernia repair.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (total).1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, bleeding.1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, organ injuries.1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, vascular.15 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, general complications (total).1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, fever.1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, urinary tract infection.1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, recurrence on 10-year follow-up.4 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pain on exertion on 10-year follow-up.1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pain at rest on 10-year follow-up.3 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pain requiring treatment on 10-year follow-up.
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Product complaint # (b)(4).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 a clinical evaluation report from a related research activity database; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch 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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