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 09APR2021 FOR THE PERIOD, 01MAR2021 TO 31MAR2021. ;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: 5270 SERIOUS INJURIES, 28 MALFUNCTIONS, AND 14 DEATHS ; 2. BY PATIENT PROBLEM CODE(S): ; 2100 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN ; 1607 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE ; 635 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION ; 475 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT ; 360 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT ; 287 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES ; 229 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY ; 163 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE ; 73 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY ; 55 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE ; 51 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE ; 48 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL ; 42 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC ; 24 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL ; 22 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION ; 14 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH ; 11 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE ; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION ; 8 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF ; 6 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1932: INFLAMMATION ; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1498: PULMONARY EMBOLISM ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2665: INTERMENSTRUAL BLEEDING ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1930: INFECTION ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1971: NECROSIS ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1800: CYST(S), FORMATION OF ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1856: FETAL DISTRESS ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2108: TOXIC SHOCK SYNDROME ; 3. BY DEVICE PROBLEM CODE(S): ; 4959 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM ; 353 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 1069: BREAK ; B. THE AVERAGE PATIENT DEMOGRAPHICS: 36.3 YEAR OLD FEMALES FROM THE UNITED STATES BASED ON A SAMPLE SIZE OF 2863 OF 5312 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 ;THE FINAL ANALYSIS OF THE MENTIONED INFORMATION WILL BE CONDUCTED AS DESCRIBED WITHIN THE ESSURE VARIANCE LETTER (E2020002) DATED 24APR2020. ;