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 2020-03-27 for ESSURE ESS305 manufactured by Bayer Pharma Ag.

Event Text Entries

[186299852] This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('becoming e-free') in a female patient who had essure inserted. 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). The patient was treated with surgery (e-free). Essure was removed. At the time of the report, the medical device removal outcome was unknown. The reporter considered medical device removal to be related to essure. The following information was received from social media: medical device removal quality-safety evaluation of ptc: unable to confirm complaint. Based on the available information, a review of our complaint records and other relevant data was 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 Number2951250-2020-02772
MDR Report Key9888627
Report SourceCONSUMER,OTHER
Date Received2020-03-27
Date of Report2020-04-02
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-27
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 Received2020-03-27
Model NumberESS305
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2020-03-27

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