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This marker fda 3500a form for medical device reporting variance e2020002 for the essure system ((b)(4)) submitted by bayer on 10jul2020 for the period, 01jun2020 to 30jun2020.A spreadsheet of mdr line-item data for the events referenced in this report can be found on the "problems reported with essure" page of the fda web site.Total number of events: by report type: 53 deaths, 1375 serious injuries, and 25 malfunctions.(b)(4).The average patient demographics: 29.5 year old females from the united states.Report source: legal.Entities submitting events: bayer pharma ag.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.
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This is a follow-up marker fda 3500a form for medical device reporting variance e2020002 for the essure system ((b)(4)) submitted by bayer on 10jul2020 for the period, 01jun2020 to 30jun2020.
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: 53 deaths, 1376 serious injuries, and 24 malfunctions
2.By patient problem code(s):
852 reports associated with patient problem code 3191: no code available
130 reports associated with patient problem code 2687: foreign body in patient
115 reports associated with patient problem code 2121: uterine perforation
97 reports associated with patient problem code 1994: pain
78 reports associated with patient problem code 3165: device fragments in patient
74 reports associated with patient problem code 3193: pregnancy
52 reports associated with patient problem code 1802: death
25 reports associated with patient problem code 1855: death, intrauterine fetal
17 reports associated with patient problem code 1819: pregnancy, ectopic
12 reports associated with patient problem code 1907: hypersensitivity
11 reports associated with patient problem code 2001: perforation
8 reports associated with patient problem code 1685: pain, abdominal
8 reports associated with patient problem code 2668: bowel perforation
7 reports associated with patient problem code 1888: hemorrhage
7 reports associated with patient problem code 2060: scar tissue
7 reports associated with patient problem code 2465: labor, premature
6 reports associated with patient problem code 1877: hair loss
6 reports associated with patient problem code 1962: miscarriage
6 reports associated with patient problem code 1987: organ(s), perforation of
4 reports associated with patient problem code 1732: autoimmune disease
4 reports associated with patient problem code 1800: cyst(s), formation of
4 reports associated with patient problem code 1932: inflammation
4 reports associated with patient problem code 2666: heavier menses
3 reports associated with patient problem code 1695: adhesion(s)
3 reports associated with patient problem code 2000: pelvic inflammatory disease
3 reports associated with patient problem code 2359: malaise
3 reports associated with patient problem code 2475: prolapse
3 reports associated with patient problem code 2607: weight fluctuations
3 reports associated with patient problem code 3262: cancer
2 reports associated with patient problem code 1688: abortion
2 reports associated with patient problem code 1733: autoimmune reaction
2 reports associated with patient problem code 1873: gangrene
2 reports associated with patient problem code 1930: infection
2 reports associated with patient problem code 2091: swelling
2 reports associated with patient problem code 2361: depression
1 report associated with patient problem code 1758: calcification
1 report associated with patient problem code 1865: flatus
1 report associated with patient problem code 1908: hypertension
1 report associated with patient problem code 1953: liver dysfunction
1 report associated with patient problem code 2033: rash
1 report associated with patient problem code 2067: sepsis
1 report associated with patient problem code 2073: sjogren's syndrome
1 report associated with patient problem code 2076: skin irritation
1 report associated with patient problem code 2153: hot flashes
1 report associated with patient problem code 2278: urticaria
1 report associated with patient problem code 2543: abdominal cramps
1 report associated with patient problem code 2601: distention
3.By device problem code(s):
1382 reports associated with device problem code 2993: no known device problem
70 reports associated with device problem code 1069: break
1 report associated with device problem code 4003: migration
b.The average patient demographics: 29.5 year old females from the united states based on a sample size of 76 of 1453 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.
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