Date sent to fda: 1/29/2019.Additional narrative: it was reported that the patient underwent mesh removal surgery on (b)(6) 2018 due to recurrent hernia and adhesions.It was also reported that following the procedure the patient experienced pain, abdominal pain, constipation, nausea, incontinence and distress.No additional information was provided.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
|