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 10NOV2020 FOR THE PERIOD, 01OCT2020 TO 31OCT2020. ;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: 3368 SERIOUS INJURIES, 13 MALFUNCTIONS, AND 5 DEATHS. ; 2. BY PATIENT PROBLEM CODE(S): ; 1301 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN. ; 975 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE. ; 346 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION. ; 307 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT. ; 287 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY. ; 251 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT. ; 147 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES. ; 114 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE. ; 79 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION. ; 68 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY. ; 66 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL. ; 52 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE. ; 31 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE. ; 22 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION. ; 18 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC. ; 14 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES. ; 12 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL. ; 9 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE. ; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF. ; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH. ; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS. ; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH. ; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION. ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S). ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1773: CERVICAL CHANGES. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2330: DISCOMFORT. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1688: ABORTION. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1754: BRUISE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1800: CYST(S), FORMATION OF. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1820: EDEMA. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1865: FLATUS. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1880: HEADACHE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1928: INCONTINENCE. ; 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 1943: ITCHING. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1944: KERATITIS. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1988: OVERDOSE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1991: OVERSTIMULATION. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2171: TINGLING. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2278: URTICARIA. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2475: PROLAPSE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2553: CONFUSION/DISORIENTATION. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2607: WEIGHT FLUCTUATIONS. ; 3. BY DEVICE PROBLEM CODE(S): ; 3138 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM. ; 248 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 833 OF 3386 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. ;