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

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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL 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 Key: 10216206
• MDR Text Key: 201219266
• Report Number: 2951250-2020-10137
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• 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 Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention