As reported, the patient experienced difficulty in passing urine, constipation and pain in the bowel area post 3dmax mesh implant.The implanting surgeon does not believe the patient's symptoms to be associated with hernia repair surgery.The patient has been diagnosed by a urologist with chronic pelvic pain syndrome.Based on the information provided, no conclusion can be made as to the degree to which the implanted mesh, may be causing or contributing the patient¿s reported symptoms.To date, this is the only reported complaint for this manufacturing lot.Review of manufacturing records indicate product was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2017.This emdr represents the bard/davol 3dmax mesh (device #2).An additional emdr was submitted to represent the bard/davol 3dmax mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned - remains implanted.
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As reported per the surgeon: on (b)(6) 2018 - the patient was implanted with two 3dmax meshes bilaterally (right and left side) in a laparoscopic inguinal hernia repair procedure.On (b)(6) 2018 - the patient was discharged.After surgery, the patient had complaints of difficulty in passing urine and constipation.The surgeon informed that the problems were not related to the mesh.On (b)(6) 2018 - the patient had follow-up visits due to pain in the bowel area near mesh implant, discomfort in lower abdomen and incomplete sense of evacuation.As reported, the patient has consulted with urologists and has been diagnosed with chronic pelvic pain syndrome (cpps) with no relation to the lap procedure.The patient is doing well with no medical or surgical intervention required.
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