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 10SEP2020 FOR THE PERIOD, 01AUG2020 TO 31AUG2020. ;;;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: 2642 SERIOUS INJURIES, 17 MALFUNCTIONS, AND 10 DEATHS;;; 2. BY PATIENT PROBLEM CODE(S):;;; 1347 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE; 633 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN; 204 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION; 131 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT; 103 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY; 93 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT; 78 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES; 52 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE; 48 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY; 41 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC; 37 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL; 23 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE; 22 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES; 22 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION; 21 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION; 13 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE; 12 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH; 8 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1865: FLATUS; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2665: INTERMENSTRUAL BLEEDING; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1971: NECROSIS; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S); 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1800: CYST(S), FORMATION OF; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1943: ITCHING; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2108: TOXIC SHOCK SYNDROME; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2607: WEIGHT FLUCTUATIONS; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2662: INTRAOPERATIVE PAIN; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1688: ABORTION; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1874: GASTRITIS; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1877: HAIR LOSS; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1930: INFECTION; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2021: PULMONARY INFARCTION; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2068: SHOCK, SEPTIC; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2134: VERTIGO; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2153: HOT FLASHES; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2193: CRAMP(S); 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2239: FIRST USE SYNDROME; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2355: ARTHRALGIA; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2358: SCAR EXCISION; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2475: PROLAPSE; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS; 1 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2553: CONFUSION/DISORIENTATION;;; 3. BY DEVICE PROBLEM CODE(S):;;; 2577 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM; 92 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 1069: BREAK;;; B. THE AVERAGE PATIENT DEMOGRAPHICS: 35 YEAR OLD FEMALES FROM THE UNITED STATES BASED ON A SAMPLE SIZE OF 480 OF 2669 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.;