Concomitant medical devices: device fixation hernia permasorb davol/bard davol - model/cat # 0113092, lot # cvug0606; device fixation hernia permasorb davol/bard davol - model/cat # 0113092, lot # cvug0606.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 an abdominal hernia.It was reported that after implant, the patient experienced adhesions, failure of mesh, infection, inflammation, and foreign body granulomas reaction.Post-operative patient treatment included revision surgery, mesh revision surgery, and mesh removal.
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