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

[186271560] This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('pelvic inflammatory disease') in an adult female patient who had essure inserted for female sterilization. The occurrence of additional non-serious events is detailed below. The patient's medical history included cholelithiasis, gravida i, cholecystitis and cholecystectomy. On (b)(6) 2009, the patient had essure inserted. On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), cystitis ("bladder infection"), urinary tract infection ("urinary tract infection ") and vaginal infection ("vaginal infection"). At the time of the report, the pelvic inflammatory disease, pelvic pain, abdominal pain, cystitis, urinary tract infection and vaginal infection outcome was unknown. The reporter considered abdominal pain, cystitis, pelvic inflammatory disease, pelvic pain, urinary tract infection and vaginal infection to be related to essure. Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram abdomen - on an unknown date: three-millimeter slices were obtained from the adrenal glands through the pelvic brim without intravenous or oral contrast. No previous studies. The kidneys are normal size and shape without hydronephrosis, mass or abnormal calcification. Visualized unenhanced abdominal organs intact. The liver may be fatty. Multiple axial computed tomographic images were obtained and there was no fluid, mass or inflammatory changes. The appendix is normal. Impression: the liver may be fatty. No obstructive uropathy or urethral calculus.. Imaging procedure - on (b)(6) 2010: essure confirmation test-result not provided. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs and mr received: new events infection (bladder/ urinary tract/vaginal) type: pelvic inflammatory disease were added case category updated to serious incident. Medical history, lab data were added. Reporter details added. 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 Number2951250-2020-02776
MDR Report Key9888638
Report SourceCONSUMER,OTHER
Date Received2020-03-27
Date of Report2020-03-27
Date Mfgr Received2018-12-06
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 Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAYER PHARMA AG
Manufacturer AddressM?LLERSTR. 178 BERLIN, 13353 GM 13353


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-27

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