Patient codes: 1930, 1994, 2240, 1695, 3189- surgical intervention.It was reported that the patient had a removal surgery on (b)(6) 2011.It was reported that following the procedure the patient experienced infection, pain, repair of recurrent ventral hernia and adhesion.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.(b)(4) submitted for adverse event which occurred on (b)(4).(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
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