ESSURE ESS305

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-11-29 for ESSURE ESS305 manufactured by Bayer Pharma Ag.

MAUDE Entry Details

Report Number2951250-2019-11859
MDR Report Key9391860
Report SourceCONSUMER,OTHER
Date Received2019-11-29
Date of Report2019-11-29
Date Mfgr Received2019-11-18
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactK SHAW LAMBERSON
Manufacturer Street100 BAYER BLVD, P.O. BOX 915
Manufacturer CityWHIPPANY NJ 07981
Manufacturer CountryUS
Manufacturer Postal07981
Manufacturer G1BAYER PHARMA AG
Manufacturer StreetM
Manufacturer CityBERLIN, 13353
Manufacturer CountryGM
Manufacturer Postal Code13353
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESSURE
Generic NameTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Product CodeHHS
Date Received2019-11-29
Model NumberESS305
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBAYER PHARMA AG
Manufacturer AddressM?LLERSTR. 178 BERLIN, 13353 GM 13353


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-11-29

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