At this time no conclusions can be made to what extent the bard/davol perfix plug device may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery for recurrent hernia and partial removal of the device.The mesh was unwrapped from the spermatic cord and removed in a piecemeal fashion; however, no sample has been returned for evaluation.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.A review of the manufacturing 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.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
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The following was alleged by the patient's attorney: (b)(6) 2013: the patient underwent left inguinal hernia repair.A bard/davol perfix plug was implanted in the patient during this repair.On (b)(6) 2014: the patient underwent surgery for treatment of groin pain, a recurrent hernia and partial mesh.Upon entering the patient's abdomen, the surgeon observed that "where the mesh was wrapped around the spermatic cord, it was fairly scarred in." as a result, the mesh was unwrapped from the spermatic cord and removed in a piecemeal fashion.Patient suffered and continues to suffer from severe pain, diarrhea, chills, hot and cold flashes, inflammation, loss of appetite and discomfort, which affect his everyday life.Patient also requires ongoing physical care and treatment.Patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability and impairment.
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