Additional Manufacturer Narrative · 1
THIS IS THE MARKER FDA 3500A FORM FOR MEDICAL DEVICE REPORTING VARIANCE E2020002 FOR THE ESSURE SYSTEM (P020014) SUBMITTED BY BAYER ON 08JAN2021 FOR THE PERIOD, 01DEC2020 TO 31DEC2020.;A SPREADSHEET OF MDR LINE-ITEM DATA FOR THE REPORTS REFERENCED IN THIS REPORT CAN BE FOUND ON THE "PROBLEMS REPORTED WITH ESSURE" PAGE OF THE FDA WEB SITE. ; A. TOTAL NUMBER OF REPORTS:; 1. BY REPORT TYPE: 4925 SERIOUS INJURIES, 25 MALFUNCTIONS, AND 5 DEATHS.; 2. BY PATIENT PROBLEM CODE(S):; 2313 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE.; 1418 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN.; 376 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT.; 343 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION.; 230 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY.; 219 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT.; 133 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES.; 97 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION.; 90 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY.; 77 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE.; 69 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE.; 58 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL.;. 40 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC.; 26 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION.; 16 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE.; 15 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL.; 14 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES.; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF.; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE.; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION.; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1880: HEADACHE.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3167: FIBROSIS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1154: WOUND DEHISCENCE.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S).; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1829: EMBOLISM.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1889: HEMORRHAGE, CEREBRAL.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1930: INFECTION.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1932: INFLAMMATION.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1971: NECROSIS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2068: SHOCK, SEPTIC.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2100: THROMBOSIS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2120: INFECTION, URINARY TRACT.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2278: URTICARIA.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2607: WEIGHT FLUCTUATIONS.; 3. BY DEVICE PROBLEM CODE(S):; 4741 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM.; 214 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 1069: BREAK.; B. THE AVERAGE PATIENT DEMOGRAPHICS: 34.7 YEAR OLD FEMALES FROM THE UNITED STATES BASED ON A SAMPLE SIZE OF 593 OF 4955 REPORTS WHERE A PATIENT AGE WAS REPORTED.; C. REPORT SOURCE: LEGAL - ALL REPORTS ARE FROM THE TWO SOURCES DESCRIBED WITHIN THE ESSURE VARIANCE LETTER (E2020002) DATED 24APR2020.; D. ENTITIES SUBMITTING REPORTS: BAYER PHARMA AG.; E. DEVICE(S) INVOLVED: ESSURE; ESS205, ESS305.;AN ANALYSIS OF THE MENTIONED INFORMATION WILL BE CONDUCTED PERIODICALLY AS DESCRIBED WITHIN THE ESSURE VARIANCE LETTER (E2020002) DATED 24APR2020.;