Concomitant devices: baxter bioscience, surgiflo hemostatic sealant, lot# 160541, exp.Date: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced hernia recurrence, mesh shrinkage, mesh migration, nerve damage, pain, and suffering.Post-operative patient treatment included revision surgery.
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