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 10MAR2021 FOR THE PERIOD, 01FEB2021 TO 28FEB2021. ;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: 12646 SERIOUS INJURIES, 262 MALFUNCTIONS, AND 7 DEATHS ; 2. BY PATIENT PROBLEM CODE(S): ; 4444 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN ; 2876 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE ; 1841 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION ; 1742 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT ; 1245 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT ; 953 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY ; 561 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES ; 371 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL ; 316 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE ; 285 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC ; 263 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY ; 260 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE ; 157 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE ; 116 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION ; 62 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION ; 41 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL ; 28 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF ; 18 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION ; 15 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES ; 14 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE ; 12 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S) ; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2665: INTERMENSTRUAL BLEEDING ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2060: SCAR TISSUE ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2358: SCAR EXCISION ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1688: ABORTION ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1932: INFLAMMATION ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1800: CYST(S), FORMATION OF ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1906: HYPERPLASIA ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2061: SCARRING ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2123: VAGINAL DISCHARGE ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2208: RUPTURE ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2355: ARTHRALGIA ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2475: PROLAPSE ; 3. BY DEVICE PROBLEM CODE(S): ; 11811 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM ; 1104 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 1069: BREAK ; B. THE AVERAGE PATIENT DEMOGRAPHICS: 36.2 YEAR OLD FEMALES FROM THE UNITED STATES BASED ON A SAMPLE SIZE OF 3401 OF 12915 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. ;