Concomitant product: lpg1510al 10x15 cm lp antmcl mesh lt (lot# unknown), ppds1510 mesh parietene ds 15x10 cm x1 (lot# unknown), ppds12 mesh parietene ds rnd 12 cm x1 (lot# eta2395x).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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced hernia recurrence, failure of mesh, pain, scarring, and inflammation.Post-operative patient treatment included revision surgery and placement of additional mesh.
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