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.Clinical code: (b)(4) operative complications.Component code: (b)(4) device not returned.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.Events related to open elective unilateral inguinal procedure reported via mw # 2210968-2022-05210.
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This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing open elective incisional procedure.Perioperative outcomes and 1-year follow-up outcomes.7 patients had perioperative complication during 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 incisional).1 patient had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (bleeding incisional).6 patients had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (organ injuries incisional).6 patients had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (bowel incisional).3 patients had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (general complications total incisional).1 patient had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (fever incisional).1 patient had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (pneumonia incisional).2 patients had perioperative complication during the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (other incisional).10 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (total incisional).2 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (bleeding incisional).4 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (seroma incisional).1 patient had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (prolonged ileus or obstruction incisional).1 patient had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (bowel injury/anastomotic insufficiency incisional).4 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (wound healing disorder incisional).3 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (complications-related reoperations incisional).6 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (recurrence on 1-year follow-up incisional).16 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (pain on exertion on 1-year follow-up incisional).10 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (pain at rest on 1-year follow-up incisional).4 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (pain requiring treatment on 1-year follow-up incisional).2 patients had perioperative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (seroma on 1-year follow-up incisional).
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