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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') 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 fetal heart rate, hemorrhage (nos), abdominal pain, pain, vaginal burning sensation, bacterial vaginosis, vaginal dryness, heavy periods, vaginal itching, vulval itching, dermatophytosis of groin, vaginal redness, dryness vaginal, itching, vaginal discharge, dry skin, bloody stool, anemia, vaginitis, vulvovaginitis, dermatophytosis, flu, vulval itching, vaginal pain, back pain, dysuria, tinea cruris, stomach pain, nausea, nickel sensitivity, vaginal infection, gastroenteritis, late period, bloating, vaginal irritation, vaginal burning sensation, cramp in lower abdomen, coital bleeding, dyspareunia, urination difficulty, gas pain, uti, nocturia, post procedural discharge, leukorrhea, tinea cruris, irregular menstruation, diarrhea, stomach discomfort, weight loss, major depressive disorder, nickel sensitivity, kidney infection, perineal pain, lower abdominal pain, abdominal distension, ruq pain, flank pain, upper abdominal pain, irregular menstruation, leukorrhea, cholesterol levels raised, gallbladder cancer, drug allergy, rash, leukorrhea, abnormal weight gain, taste metallic, kidney stones, urgency urination, erythema, hyperlipidemia, gallbladder removal, depression, anxiety and seasonal allergy. Concomitant products included calcium carbonate (tums 500 calcium), omeprazole, sucralfate (carafate), sulfamethoxazole and trimethoprim. On (b)(6) 2011, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), allergy to metals ("nickel sensitivity"), dyspareunia ("dyspareunia"), hypersensitivity ("allergic reaction"), pruritus ("itching and tearing in my down"), vulvovaginal swelling ("itchy swollen labias"), migraine ("horrible migraines"), abdominal pain ("excruciating cramps"), abdominal distension ("always bloated") and discomfort ("very uncomfortable") and was found to have weight increased ("gained almost 40 lbs"). The patient was treated with surgery (robotic-assisted laparoscopic total hysterectomy with bilateral salpingectomy). Essure was removed on (b)(6) 2017. At the time of the report, the pelvic pain, allergy to metals, dyspareunia, hypersensitivity, pruritus, vulvovaginal swelling, migraine, abdominal pain, weight increased, abdominal distension and discomfort outcome was unknown. The reporter considered abdominal distension, abdominal pain, allergy to metals, discomfort, dyspareunia, hypersensitivity, migraine, pelvic pain, pruritus, vulvovaginal swelling and weight increased to be related to essure. The reporter commented: legacy device report num 2951250-2019-01008 medwatch 3500a mfr number. Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: fallopian tubes are occluded. ¿concerning the injuries reported in this case, the following one/ones were described in social media: adverse event". Quality-safety evaluation of ptc: unable to confirm complaint. Amendment: the report was amended for the following reason: this record was detected to be a duplicate to record (b)(4) which will be deleted (b)(4) which will be retained. From deletion case (b)(4) event pain, nickel sensitivity, dyspareunia, allergic reaction, itching and tearing in my down, itchy swollen labias, horrible migraines, excruciating cramps, gained almost 40 lbs, always bloated, very uncomfortable, drug withdrawn were added. Event adverse reaction were deleted. Device category changed from device other event to incident. Medical history, reporter information, concomitant drug, lab data were added. No new follow-up information was received from the reporter. 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.

 
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Brand NameESSURE
Type of DeviceTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd, p.o. box 915
whippany, NJ 07981
MDR Report Key10216206
MDR Text Key201219266
Report Number2951250-2020-10137
Device Sequence Number1
Product Code HHS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberESS305
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
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