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 10DEC2020 FOR THE PERIOD, 01NOV2020 TO 30NOV2020. ;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: 3624 SERIOUS INJURIES, 17 MALFUNCTIONS, AND 2 DEATHS. ; 2. BY PATIENT PROBLEM CODE(S): ; 1293 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN. ; 1147 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE. ; 390 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT. ; 316 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION. ; 267 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY. ; 220 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT. ; 144 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES. ; 113 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE. ; 95 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL. ; 91 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY. ; 82 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION. ; 74 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE. ; 25 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC. ; 18 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION. ; 15 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES. ; 15 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE. ; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL. ; 6 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF. ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH. ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS. ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION. ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S). ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE. ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1690: ABSCESS. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2681: TISSUE BREAKDOWN. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1028: ANASTOMOSE, FAILURE TO. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1204: VESSEL OR PLAQUE, DEVICE EMBEDDED IN. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1880: HEADACHE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1932: INFLAMMATION. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1946: LACERATION(S). ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1957: CYTOMEGALOVIRAL RETINITIS. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2022: PULMONARY INSUFFICIENCY. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2060: SCAR TISSUE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2278: URTICARIA. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2348: INJURY. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2475: PROLAPSE. ; 3. BY DEVICE PROBLEM CODE(S): ; 3423 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM. ; 220 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 1069: BREAK. ; B. THE AVERAGE PATIENT DEMOGRAPHICS: 34.4 YEAR OLD FEMALES FROM THE UNITED STATES BASED ON A SAMPLE SIZE OF 739 OF 3643 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. ;