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 Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Pain (1994); Cramp(s) (2193); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.D23516, d23515) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included pancreatectomy in 2008, splenectomy in 2008, parathyroidectomy, cholecystectomy and morbid obesity.Concurrent conditions included multiple endocrine neoplasia type 1.On (b)(6) 2016, the patient had essure inserted.In 2017, the patient experienced genital haemorrhage ("general abnormal bleed"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia") and vaginal haemorrhage ("abnormal bleeding (vaginal)").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping"), psychological trauma ("psych injury"), fatigue ("fatigue") and dysmenorrhoea ("dysmenorrhea (cramping)").The patient was treated with surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, abdominal pain, menorrhagia and vaginal haemorrhage had resolved and the genital haemorrhage, dyspareunia, abdominal pain lower, psychological trauma, fatigue and dysmenorrhoea outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, menorrhagia, pelvic pain, psychological trauma and vaginal haemorrhage to be related to essure.The reporter commented: on right side of tube 6 coils and left side 5 coils were noted as per pfs discrepancy noted in date of insertion: (b)(6) 2016 discrepancy noted in essure confirmation test.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.2 kg/sqm.Imaging procedure - on (b)(6) 2016: essure confirmation test(s) (unspecified) - bilateral occlusion.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records : abdominal pain lot number: d23515 manufacturing date: 2014-10 expiration date: 2017-10.Lot number: d23516 manufacturing date: 2014-10 expiration date: 2017-10.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-feb-2020: pfs received events "abnormal bleeding (vaginal), dysmenorrhea (cramping)" were added.Outcome of event "abnormal bleeding, pelvic and abdominal pain" were updated as recovered.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: 9726869
• MDR Text Key: 190008078
• Report Number: 2951250-2020-01545
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: ESS305
• Device Lot Number: D23516, D23515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Patient Weight: 88