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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 Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Ectopic Pregnancy (1819); Death, Intrauterine Fetal (1855); Pain (1994); Perforation (2001); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Pregnancy (3193)
Event Type  Injury  
Manufacturer Narrative

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.

 
Manufacturer Narrative

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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Brand NameESSURE
Type of DeviceTRANSCERVICAL 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 
MDR Report Key10260064
MDR Text Key198513902
Report Number2951250-2020-10578
Device Sequence Number1
Product Code HHS
Combination Product (Y/N)N
PMA/PMN NumberP020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2020
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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