Product complaint # (b)(4).Additional information of index procedure: report of surgery from (b)(6) 2012.Post-hysterectomy genital prolapse, tricompartmental, without urinary incontinence.Surgical approach : vaginal.Anterior sagittal colpotomy after infiltration with diluted xylocaine adrenaline.Dissection of the cystocele and opening of the para-vesical fossae which is more difficult on the left side.Spine spotting sciatica of the tendon arch and the posterior surface of the obturator foramen.Posterior sagittal coipotomy after infiltration with diluted xylocaine adrenaline, leaving an apical vaginal bridge approximately 3 cm between the two colpotomies.Dissection of the rectocele and opening of the ischio-rectal fossae and identification of the sacroépinous ligament.At the apical level, a tunnel is created behind the vaginal bridge, about 2 cm wide, allowing the apical prosthesis to be threaded.Placement of a total prolift (polypropylene) with an anterior subbladder part secured to the tendon arch of the pelvic fascia by two arms on each side, an apical part behind the apex and a pre-rectal part attached to the sacra-spinous ligament by one arm on each side exiting via the retro anal translevatorian approach.Solidarity of the anterior prosthesis to the fascia under the bladder neck by two stitch of vicryl rapid.Blue bladder test confirming bladder integrity.The absence of tension is checked at the apical portion of the prosthesis.Tr to debride the rectum.Vaginal mesh and indwelling probe 24h.Cutaneous suture with vicryl rapid. the following information was requested, but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? product code and lot #.Were any concomitant procedures performed? results of the medical intervention given for the pain management? if reoperation was performed please provide date and surgical findings was the device removed? if so, please date and details of the re-operation.The initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? mesh exposure symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what medical intervention was performed for the urinary tract infection? results? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? adverse events for the patient's event on (b)(6) 2012 reported via mw # 2210968-2021-04355.Adverse events for the patient's event on (b)(6) 2013 event reported via mw # 2210968-2021-04356.Adverse events for the patient's event on (b)(6) 2013 reported via mw # 2210968-2021-04357.
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It was reported that a patient underwent a patient underwent a gynecological procedure for post-hysterectomy genital prolapse, tricompartmental on (b)(6) 2012 and the mesh was implanted.It was reported that the postoperative effects were marked by difficulty resuming urination but which ultimately standardized.It was also reported that the patient had burning sensations and vaginal pain.At the exam, the anatomical result was satisfactory but there was a median synechia with painful hyperesthesia of the vagina which the doctor opined to be related to mucous atrophy.There is no prosthetic exposure.The patient was given a prescription of a local treatment.Additional information was requested.
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