At this time no conclusions can be made to what extent the bard/davol bard flat mesh (device #2) device may have caused or contributed to the reported event.Regarding infection; the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed." a manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol bard flat mesh (device #2).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #1 and device #3).Not returned.
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The following was alleged by the patient's attorney patient fact sheet and medical records: (b)(6) 2005: the patient was diagnosed with a large recurrent gluteal enterocele, recurrent cystocele and underwent repair with implant of a bard/davol bard flat mesh (device #1).On (b)(6) 2008: the patient as diagnosed with a large perirectal fascia hernia with large enterocele, right gluteal mass and underwent reduction of enterocele and closure with implant of a bard/davol bard flat mesh (device #2) followed by cystoscopy.On (b)(6) 2008: the patient was diagnosed with a recurrent right gluteal hernia and underwent a repeat grafting of gluteal hernia with implant of a bard/davol bard flat mesh (device #3).On (b)(6) 2008: the patient was diagnosed with pain of left buttocks, mild recurrence of hernia in the left buttocks and underwent a revision of left gluteal hernia and removal of permanent suture material (non bard/davol).On (b)(6) 2009: the patient was diagnosed with a recurrent gluteal hernia on right side and underwent implant of an "avaulta" (non davol) mesh for recurrent gluteal enterocele.On (b)(6) 2009: the patient was diagnosed with a non-healing wound due to a bacterial infection of the right buttock, erosion of unspecified ¿graft material¿ and underwent multiple excisions of the eroded graft followed by revision of wound.On (b)(6) 2009: the patient was diagnosed with a recurrent gluteal hernia defect with enterocele and underwent placement of a non bard/davol ¿surgipro¿ mesh.On (b)(6) 2010, (b)(6) 2011: the patient was diagnosed with a recurrent erosion of right gluteal graft (unspecified), recurrent large enterocele and underwent wound revision, excision of eroded ¿grafting material¿ (unspecified) and herniorrhaphy.On (b)(6) 2013: the patient was diagnosed with recurrent perineal hernia and underwent exploratory laparotomy, extensive lysis of adhesions, excision of perineal and vaginal mesh x3, cysystoscopy, repair of perineal hernia with unspecified biologic graft, repair of enterotomy and bilat ureterolysis.On (b)(6) 2013: the patient was diagnosed with exposed ¿prolene mesh¿ (unspecified) of the right vulvar region and underwent excision of exposed graft.Alleged outcomes attributed to device of pain, erosion, extrusion, infection, urinary problems, bowel problems, recurrence, bleeding, dyspareunia, neuromuscular problems and vaginal scarring.
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