The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the pelvilace¿ biourethral support system may include, but are not limited to: postoperative hematoma.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage." (b)(4).
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It was reported in the patient¿s medical records received that as a result of having the product implanted, the patient has experienced mixed incontinence, positive urine culture, frequency, nocturia, pyuria, abnormal urinary stream, fecal and flatus incontinence, recurrent stress incontinence, urgency of urination, urinary frequency, midline cystocele, urge incontinence, pelvic pain, pressure, nonsurgical interventions and one surgical intervention.
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