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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abortion (1688); Abscess (1690); Adhesion(s) (1695); Autoimmune Disorder (1732); Chest Pain (1776); Death (1802); Ectopic Pregnancy (1819); Fatigue (1849); Death, Intrauterine Fetal (1855); Headache (1880); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Menstrual Irregularities (1959); Miscarriage (1962); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Pelvic Inflammatory Disease (2000); Perforation (2001); Peritoneal Laceration(s) (2003); Rash (2033); Scar Tissue (2060); Sepsis (2067); Tinnitus (2103); Uterine Perforation (2121); Cramp(s) (2193); Dizziness (2194); Rupture (2208); Urticaria (2278); Arthralgia (2355); Depression (2361); Premature Labor (2465); Prolapse (2475); Abdominal Cramps (2543); Abdominal Distention (2601); Pseudoaneurysm (2605); Intermenstrual Bleeding (2665); Heavier Menses (2666); Bowel Perforation (2668); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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.
.
 
Manufacturer Narrative
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.
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Brand Name
ESSURE
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM  13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM   13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd
p.o. box 915
whippany, NJ 07981
MDR Report Key10819440
MDR Text Key215903504
Report Number2951250-2020-14805
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/07/2021
Type of Device Usage N
Patient Sequence Number1
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