Currently, it is unknown to what extent the device may have caused or contributed to the reported event.It was alleged the patient experienced infection.In regards to 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.¿ with the current information available, no conclusion can be made.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
|
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2012 - the patient was diagnosed with pelvic floor prolapse with genital and rectal prolapse and right ovarian cyst.The patient underwent a total pelvic mesh repair (tpmr) with a bilateral salpingo-oophorectomy with implant of a bard/davol flat mesh.The attorney alleges the patient experienced chronic bladder infections, urine retention, chronic pain/swelling and has sought additional treatment related to the mesh.
|