At this time no conclusions can be made to what extent the bard/davol composix kugel(device#2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.Adhesions is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Information is limited at this time.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.An unresolved infection, however, may require removal of the prosthesis¿.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix kugel(device #2).An additional emdr was submitted to represent the bard/davol composix kugel(device #1).An additional emdr was submitted to represent the bard/davol composix kugel(device #3).
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The following was alleged by the patient's attorney: on (b)(6) 2006: the patient underwent repair of ventral hernias.It is alleged that an a composix kuge(device #1), and composix kugel(device #2) , as well as a composix kugel hernia patch size large (device #3), were implanted in patient during this repair.On (b)(6) 2017:the patient underwent surgery to remove the infected composix kugel(device #1, device #2 and device #3).It is alleged that during the surgery, the surgeon noted, "explanted mesh in multiple pieces and a portion of small bowel that was attached to the mesh" and "upper midline wound with exposed mesh that was heaped up and coming out of the wound".The composix kugel(device #1, device #2 and device #3) implanted in the patient failed to reasonably perform as intended.The composix kugel(device #1, device #2 and device #3) caused serious injury and had to be surgically removed via invasive surgery.It is alleged that the patient continues to experience complications related to the composix kugel(device #1, device #2 and device #3) and will likely require additional surgeries to repair the damage from the "defective" product.The composix kugel(device #1, device #2 and device #3) implanted in the patient failed to reasonably perform as intended and allegedly caused serious injury, sustained severe and permanent pain, suffering, anxiety, depression, disability and impairment.
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