IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED LEAKAGE OF URINE, RECURRENT STRESS INCONTINENCE, INTRINSIC SPHINCTER DYSFUNCTION REQUIRING CYSTOSCOPY, PERIURETHRAL INJECTION OF MACROPLASTIQUE BULKING AGENT AS WELL AS TVT EXACT WITH ADJUSTABLE SUTURE, FREQUENCY, URGENCY, DIFFICULTIES WITH CONSTIPATION, PROBABLE SCARRING OF BLADDER NECK, NOCTURIA, INCREASED ABDOMINAL PRESSURE, TRIAL BLADDER TRAINING PROGRAM, CYSTITIS, RECURRENT BLADDER AND URINARY INFECTIONS, PAIN AND DYSPAREUNIA.
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Patient 1
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 REACTIONS: COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE AVAULTA SOLO? SYNTHETIC SUPPORT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE). EXEMPTION (B)(4). THE TOTAL NUMBER OF EVENTS FOR PRODUCT CLASSIFICATION CODE OTP IS (B)(4). (B)(4)- AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM. (B)(4)- AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE. (B)(4)- AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR, STERILE. (B)(4)- AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE. (B)(4)- AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR, STERILE. (B)(4)- UNKNOWN BMD WOMEN'S HEALTH PRODUCT. (B)(4). PT AGE: DOB (B)(6) 1948.