This complaint is being opened in association with the alleged event filed by the patient's attorney in complaint numbers (b)(4).There have been no allegations of deficiency or serious injury against this device.This device is listed in the patient's medical records.Per additional information received, the patient has experienced stress urinary incontinence, pain, unspecified urinary problems, recurrence, infection, bleeding, irritative voiding symptoms, mixed urinary incontinence, urinary tract infections, incomplete bladder emptying, urethrovesical junction with incomplete coaptation, urinary incontinence, frequency, urgency/urge incontinence, urinary leakage, functional incontinence, atrophic vulva/vaginal tissues, sore spots, dysuria, not eliminating balder irritants, vomits with ingestion of water, trouble sustaining contractions, pelvic floor weakness, post micturition dribbling, narrowing at the introitus, decreased muscle bulk at vaginal vault, shortening of pelvic floor muscles, peripheral edema, short of breath/lying down, itching, unusual weight gain/loss, abdominal/suprapubic pain, chills, sleep disorder, sweats, bed wetting, burring with urination (burning sensation), lower back pain, muscle cramps/weakness, stiffness, increased urine output, wheezing, gas bloating, up 3-5 times per night to void, distended bladder, atrophic vaginitis (inflammation), fecal incontinence, renal cyst, bladder decompressed by catheter/wall thickening, malodorous urine, yeast infection/dermatitis, dry mouth, blood in urine (hematuria), wide open urethra/pipe stem, collagen residual at bladder neck, urethral dysfunction/pain, red around stitches, pelvic/urethral pain, nocturnal enuresis, lightheadedness, dizziness, unquenchable thirst, detrusor instability, trabeculations, increased bladder sensation, decreased bladder capacity, compliance, weak stream, suture material midureteral area, high bladder neck, narrow/stenotic vagina, sphincter incompetency, quiescent bladder, scarring, hematoma, blood loss, urethral hypermobility, hiatal hernia, low red blood cell count/hemoglobin, diarrhea, unable to void/difficulty urinating, candidiasis of vulva/vagina (fungal infection), urinary retention, dizzy, low red blood cell/hemoglobin/hematocrit and required nonsurgical and additional surgical interventions.
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