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 2020-03-26 for ESSURE ESS305 manufactured by Bayer Pharma Ag.

Event Text Entries

[186126239] This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('tubes removed') in a female patient who had essure inserted. The occurrence of additional non-serious events is detailed below. On an unknown date, the patient had essure inserted. On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced nervousness ("nervous"). The patient was treated with surgery (salpingectomy). Essure was removed. At the time of the report, the medical device removal and nervousness outcome was unknown. The reporter considered medical device removal and nervousness to be related to essure. Concerning the injuries reported in this case, the following one was reported via social media: medical device removal. Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951250-2020-02756
MDR Report Key9886097
Report SourceCONSUMER,OTHER
Date Received2020-03-26
Date of Report2020-04-02
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-26
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 Received2020-03-26
Model NumberESS305
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
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 2020-03-26

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