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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