MAUDE MDR 9391861

MDR report key: 9391861
Report number: 2951250-2019-11866
Event key: 0
Event type: 3
Date received: 2019-11-29
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: K SHAW LAMBERSON
Address: 100 BAYER BLVD, P.O. BOX 915 WHIPPANY NJ 07981 US
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	ESSURE	TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE	BAYER PHARMA AG	HHS	ESS305						*	*

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0	1. O; 2. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00888853030517	Essure	Bayer Healthcare LLC	HHS	2014-09-04
10888853003051	Essure	Bayer Healthcare LLC	HHS	2014-09-04
20888853003058	Essure	Bayer Healthcare LLC	HHS	2014-09-04

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P020014S051	HHS	Essure System for Permanent Birth Control	Bayer Pharma AG	2018-04-09
PMA	P020014S050	HHS	Essure System for Permanent Birth Control	Bayer Pharma AG	2018-03-22
PMA	P020014S049	HHS	Essure System for Permanent Birth Control	Bayer Pharma AG	2017-12-04
PMA	P020014S048	HHS	ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL	Bayer Pharma AG	2016-12-14
PMA	P020014S046	HHS	ESSURE SYSTEM	Bayer Pharma AG	2016-11-15