|
This is the marker fda 3500a form for medical device reporting variance e2020002 for the essure system ((b)(4)) submitted by bayer on 10aug2020 for the period, 01jul2020 to 31jul2020.
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: 3314 serious injuries, 63 malfunctions, and 10 deaths
2.By patient problem code(s):
1019 reports associated with patient problem code 3191: no code available.
624 reports associated with patient problem code 1994: pain.
600 reports associated with patient problem code 2121: uterine perforation.
377 reports associated with patient problem code 2687: foreign body in patient.
284 reports associated with patient problem code 3165: device fragments in patient.
248 reports associated with patient problem code 3193: pregnancy.
77 reports associated with patient problem code 1819: pregnancy, ectopic.
74 reports associated with patient problem code 1685: pain, abdominal.
65 reports associated with patient problem code 1888: hemorrhage.
60 reports associated with patient problem code 2666: heavier menses.
55 reports associated with patient problem code 1962: miscarriage.
52 reports associated with patient problem code 1907: hypersensitivity.
49 reports associated with patient problem code 2001: perforation.
36 reports associated with patient problem code 1855: death, intrauterine fetal.
30 reports associated with patient problem code 2000: pelvic inflammatory disease.
25 reports associated with patient problem code 1688: abortion.
23 reports associated with patient problem code 2607: weight fluctuations.
21 reports associated with patient problem code 1959: menstrual irregularities.
18 reports associated with patient problem code 1877: hair loss.
17 reports associated with patient problem code 2355: arthralgia.
16 reports associated with patient problem code 2668: bowel perforation.
13 reports associated with patient problem code 2033: rash.
13 reports associated with patient problem code 2060: scar tissue.
13 reports associated with patient problem code 2601: distention.
11 reports associated with patient problem code 1880: headache.
11 reports associated with patient problem code 1987: organ(s), perforation of.
11 reports associated with patient problem code 2328: anxiety.
10 reports associated with patient problem code 1800: cyst(s), formation of.
10 reports associated with patient problem code 1802: death.
10 reports associated with patient problem code 1865: flatus.
9 reports associated with patient problem code 2475: prolapse.
8 reports associated with patient problem code 2091: swelling.
7 reports associated with patient problem code 2359: malaise.
7 reports associated with patient problem code 2361: depression.
6 reports associated with patient problem code 1732: autoimmune disease.
6 reports associated with patient problem code 1932: inflammation.
6 reports associated with patient problem code 2465: labor, premature.
5 reports associated with patient problem code 1695: adhesion(s).
5 reports associated with patient problem code 2102: thyroid problems.
5 reports associated with patient problem code 3262: cancer fda.
4 reports associated with patient problem code 1849: fatigue.
4 reports associated with patient problem code 2348: injury.
3 reports associated with patient problem code 1831: emotional changes.
3 reports associated with patient problem code 1928: incontinence.
3 reports associated with patient problem code 1930: infection.
3 reports associated with patient problem code 2067: sepsis.
3 reports associated with patient problem code 2330: discomfort.
3 reports associated with patient problem code 2375: fasciitis.
3 reports associated with patient problem code 3274: constipation.
2 reports associated with patient problem code 1204: vessel or plaque, device embedded in.
2 reports associated with patient problem code 1498: pulmonary embolism.
2 reports associated with patient problem code 1724: arthritis, rheumatoid.
2 reports associated with patient problem code 1735: infection, bacterial.
2 reports associated with patient problem code 1884: hematoma.
2 reports associated with patient problem code 1958: memory loss.
2 reports associated with patient problem code 1966: muscle spasm(s).
2 reports associated with patient problem code 1970: nausea.
2 reports associated with patient problem code 2240: hernia.
2 reports associated with patient problem code 2278: urticaria.
2 reports associated with patient problem code 2415: numbness.
2 reports associated with patient problem code 2428: fracture, tooth.
1 report associated with patient problem code 1610: syncope.
1 report associated with patient problem code 1706: anemia.
1 report associated with patient problem code 1710: angina.
1 report associated with patient problem code 1726: asthma.
1 report associated with patient problem code 1759: cancer, breast.
1 report associated with patient problem code 1773: cervical changes.
1 report associated with patient problem code 1808: dementia.
1 report associated with patient problem code 1829: embolism.
1 report associated with patient problem code 1874: gastritis.
1 report associated with patient problem code 1887: hemoptysis.
1 report associated with patient problem code 1908: hypertension.
1 report associated with patient problem code 1952: ligament(s), damage to.
1 report associated with patient problem code 1954: liver dysfunction.
1 report associated with patient problem code 1969: myocardial infarction.
1 report associated with patient problem code 1979: nerve damage.
1 report associated with patient problem code 2011: pneumonia.
1 report associated with patient problem code 2021: pulmonary infarction.
1 report associated with patient problem code 2034: raynauds phenomenon.
1 report associated with patient problem code 2039: renal disease, end stage.
1 report associated with patient problem code 2041: renal failure.
1 report associated with patient problem code 2072: shock.
1 report associated with patient problem code 2073: sjogren's syndrome.
1 report associated with patient problem code 2101: thrombus.
1 report associated with patient problem code 2120: infection, urinary tract.
1 report associated with patient problem code 2139: vision, loss of.
1 report associated with patient problem code 2146: burning sensation.
1 report associated with patient problem code 2153: hot flashes.
1 report associated with patient problem code 2156: immuno-deficiency.
1 report associated with patient problem code 2191: chills.
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 2214: abortion, induced.
1 report associated with patient problem code 2238: myalgia.
1 report associated with patient problem code 2275: urinary frequency.
1 report associated with patient problem code 2352: hypoesthesia.
1 report associated with patient problem code 2353: hypoesthesia, arm/hand.
1 report associated with patient problem code 2419: infection, fungal.
1 report associated with patient problem code 2422: obstruction.
1 report associated with patient problem code 2433: pain, neck.
1 report associated with patient problem code 2467: palpitations.
1 report associated with patient problem code 2493: ischemic heart disease.
1 report associated with patient problem code 2517: sleep disturbances.
1 report associated with patient problem code 2543: abdominal cramps.
1 report associated with patient problem code 2689: nervous system injury.
1 report associated with patient problem code 2697: valvular stenosis.
1 report associated with patient problem code 3271: pericardial effusion.
3.By device problem code(s):
3102 reports associated with device problem code 2993: no known device problem.
285 reports associated with device problem code 1069: break.
b.The average patient demographics: 34 year old females from the united states based on a sample size of 357 of 3387 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.
.
|
