N
Patient 1
THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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: "THE TEGRESS? URETHRAL IMPLANT CLINICAL TRIAL INVOLVED 374 TEGRESS? IMPLANT TREATMENT INJECTIONS IN 174 SUBJECTS (MEAN FOLLOW-UP OF APPROXIMATELY 14 MONTHS). THERE WERE NO DEATHS AMONG STUDY PATIENTS. THE FOLLOWING TABLE LISTS THE TREATMENT RELATED ADVERSE EVENTS REPORTED DURING THE CLINICAL STUDY (INCIDENCE >2%). TREATMENT RELATED EVENTS ARE THOSE EVENTS THAT WERE DEEMED TO BE RELATED TO EITHER THE DEVICE OR THE PROCEDURE. ALL GENITOURINARY EVENTS WERE CLASSIFIED AS TREATMENT RELATED. NUMBER (%) SUBJECTS REPORTING TREATMENT RELATED ADVERSE EVENTS EVENT CATEGORY TEGRESS? IMPLANT (N=174) URINARY TRACT INFECTION (UTI) 50 (29%) DELAYED VOIDING 32 (18%) DYSURIA 31 (18%) EXPOSED MATERIAL 28 (16%) URINARY URGENCY 24 (14%) URINARY FREQUENCY 22 (13%) GENITOURINARY (INFECTION, TENDERNESS) 20 (11%) HEMATURIA 19 (11%) URGE INCONTINENCE 16 ( 9%) WORSENING OF INCONTINENCE (ONSET OF URGE) 14 ( 8%) OUTLET OBSTRUCTION 13 ( 7%) PAIN AT INJECTION SITE 13 ( 7%) PELVIC PAIN 13 ( 7%) YEAST INFECTION 12 ( 7%) LEAKAGE OF URINE/STRESS INCONTINENCE 9 ( 5%) BULKING MATERIAL INJECTED INTO BLADDER 7 ( 4%) FATIGUE 3 ( 2%) ABNORMAL URINALYSIS 3 ( 2%) BLADDER FULLNESS 3 ( 2%) NOCTURIA 3 ( 2%) PELVIC HEAVINESS 3 ( 2%) UTERINE FIBROIDS 3 ( 2%) OTHER (