Date sent to fda: 1/17/2020.H6 patient codes: 3189 - surgical intervention, 2069, 2240, 2330, 2422, 1994, 2415.Additional information: a2,d1,d2,d3,d4,d7,g1,g2.Additional b5 narrative: it was reported that the patient underwent removal surgery on (b)(6) 2017.It was reported that following the procedure the patient experienced hernia recurrence, discomfort, bowel obstruction, seromas, pain and numbness.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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