Ethicon eea product recall used in surgery color colon reaction and anastomosis; leak occurred at anastomotic site resulting in a return to surgery on (b)(6) 2018 and resulting in a temporary colostomy with a return on (b)(6) 2018 for colostomy revision due to add'l necrosis.Pt went through rehab and wound care.On (b)(6) 2019, she had surgery for the colostomy reversal and a wound vac for non-healing of the site was on (b)(6) 2019 due to abscess formation and drainage with insertion of 2 separate drainage catheters from abscessed sites.The two drains were removed on (b)(6) 2019 with a f/u abscessogram on (b)(6) 2019 with results pending at this time.The eea ethicon stapler is under a class 1 product recall dated 04/11/2019.Multiple tests and wound care / labs ordered in-between the tests as listed above and included multiple extended hospital stays.Fda safety report id# (b)(4).
|