Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
MAUDE Adverse Event Report: BAYER HEALTH ESSURE
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
BAYER HEALTH ESSURE
Back to Search Results
Device Problem
Extrusion (2934)
Patient Problems
Death (1802); Perforation (2001)
Event Date
01/22/2015
Event Type
Death
Event Description
Perforation of uterus during elective hysteroscopic tubal occlusion procedure with essure device.
Search Alerts/Recalls
New Search
|
Submit an Adverse Event Report
Brand Name
ESSURE
Type of Device
ESSURE
Manufacturer
(Section D)
BAYER HEALTH
MDR Report Key
4684438
MDR Text Key
5670510
Report Number
MW5042068
Device Sequence Number
1
Product Code
HHS
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Physician
Type of Report
Initial
Report Date
04/07/2015
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
Health Professional
Is the Reporter a Health Professional?
Yes
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
04/07/2015
Is This a Reprocessed and Reused Single-Use Device?
No
Patient Sequence Number
1
Treatment
LIDOCAINE; PREMEDICATED WITH PERCOCET,
Patient Outcome(s)
Death;
Patient Age
31 YR
Patient Weight
69
-
-