BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10819440 · Received November 10, 2020

    Report

    Report Number
    2951250-2020-14805
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP MARKER FDA 3500A FORM FOR MEDICAL DEVICE REPORTING VARIANCE E2020002 FOR THE ESSURE SYSTEM (P020014) SUBMITTED BY BAYER ON 01SEP2021 FOR THE PERIOD, 01SEP2020 TO 30SEP2020.;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: 4838 SERIOUS INJURIES, 15 MALFUNCTIONS, AND 2 DEATHS.; 2. BY PATIENT PROBLEM CODE(S):; 1727 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN.; 1670 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE.; 350 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION.; 340 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT.; 233 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY.; 187 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT.; 171 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES.; 138 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY.; 110 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE.; 108 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL.; 97 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION.; 59 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE.; 43 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC.; 38 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1688: ABORTION.; 32 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES.; 24 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION.; 20 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE.; 16 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2060: SCAR TISSUE.; 13 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH.; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL.; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE.; 9 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS.; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION.; 6 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2665: INTERMENSTRUAL BLEEDING.; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1943: ITCHING.; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S).; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1880: HEADACHE.; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1930: INFECTION.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF.; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2278: URTICARIA.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1690: ABSCESS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1732: AUTOIMMUNE DISEASE.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1776: CHEST PAIN.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1849: FATIGUE.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1884: HEMATOMA.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1932: INFLAMMATION.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1971: NECROSIS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2003: PERITONEAL LACERATION(S).; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2103: TINNITUS.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2193: CRAMP(S).; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2194: DIZZINESS.; 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 2361: DEPRESSION.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2475: PROLAPSE.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2605: PSEUDOANEURYSM.; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 3167: FIBROSIS.; 3. BY DEVICE PROBLEM CODE(S):; 4667 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM.; 188 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 1218 OF 4855 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.;FOLLOW-UP INFORMATION: REPORT 2020-187991 IS ASSOCIATED WITH MOTHER REPORT 2020-204266 AND REPORT 2020-192279 IS ASSOCIATED WITH MOTHER REPORT 2020-192817 IN THE PUBLISHED SEP-2020 SPREADSHEET.;

    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 09OCT2020 FOR THE PERIOD, 01SEP2020 TO 30SEP2020. ;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: 4838 SERIOUS INJURIES, 15 MALFUNCTIONS, AND 2 DEATHS. ; 2. BY PATIENT PROBLEM CODE(S): ; 1727 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1994: PAIN. ; 1670 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3191: NO CODE AVAILABLE. ; 350 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2121: UTERINE PERFORATION. ; 340 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2687: FOREIGN BODY IN PATIENT. ; 233 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3193: PREGNANCY. ; 187 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 3165: DEVICE FRAGMENTS IN PATIENT. ; 171 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2666: HEAVIER MENSES. ; 138 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1907: HYPERSENSITIVITY. ; 110 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1888: HEMORRHAGE. ; 108 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1685: PAIN, ABDOMINAL. ; 97 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2601: DISTENTION. ; 59 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2000: PELVIC INFLAMMATORY DISEASE. ; 43 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1819: PREGNANCY, ECTOPIC. ; 38 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1688: ABORTION. ; 32 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1959: MENSTRUAL IRREGULARITIES. ; 24 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2001: PERFORATION. ; 20 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1962: MISCARRIAGE. ; 16 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2060: SCAR TISSUE. ; 13 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2033: RASH. ; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1855: DEATH, INTRAUTERINE FETAL. ; 10 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2465: LABOR, PREMATURE. ; 9 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2543: ABDOMINAL CRAMPS. ; 7 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2668: BOWEL PERFORATION. ; 6 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2665: INTERMENSTRUAL BLEEDING. ; 5 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1943: ITCHING. ; 4 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1695: ADHESION(S). ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1880: HEADACHE. ; 3 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2067: SEPSIS. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1802: DEATH. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1930: INFECTION. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 1987: ORGAN(S), PERFORATION OF. ; 2 REPORTS ASSOCIATED WITH PATIENT PROBLEM CODE 2278: URTICARIA. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1690: ABSCESS. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1732: AUTOIMMUNE DISEASE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1776: CHEST PAIN. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1849: FATIGUE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1884: HEMATOMA. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1932: INFLAMMATION. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 1971: NECROSIS. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2003: PERITONEAL LACERATION(S). ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2103: TINNITUS. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2193: CRAMP(S). ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2194: DIZZINESS. ; 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 2361: DEPRESSION. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2475: PROLAPSE. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 2605: PSEUDOANEURYSM. ; 1 REPORT ASSOCIATED WITH PATIENT PROBLEM CODE 3167: FIBROSIS. ; 3. BY DEVICE PROBLEM CODE(S): ; 4667 REPORTS ASSOCIATED WITH DEVICE PROBLEM CODE 2993: NO KNOWN DEVICE PROBLEM. ; 188 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 1218 OF 4855 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. ;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285604 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG

    Patients

    Seq Age Sex Outcome Treatment
    1