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); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vertigo (2134); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain ¿ pelvic/abdominal') in a female patient who had essure inserted for female sterilisation and female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("pain ¿ pelvic/abdominal"), dysmenorrhoea ("dysmennorhea (cramping)"), menorrhagia ("bleeding ¿ menorrhagia (heavy menstrual bleeding)"), vertigo ("type of autoimmune diagnosed ¿ vertigo"), psychological trauma ("psych injury related to essure? yes"), bladder disorder ("bladder/urinary problems ¿ bladder probs"), urinary tract infection ("uti"), fatigue ("fatigue"), cystitis ("bladder infection") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain").The patient was treated with surgery (partial hystterectomy , bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, dysmenorrhoea, vertigo, psychological trauma, bladder disorder, urinary tract infection, fatigue, weight increased, cystitis and vaginal discharge outcome was unknown and the menorrhagia had resolved.The reporter considered abdominal pain, bladder disorder, cystitis, dysmenorrhoea, fatigue, menorrhagia, pelvic pain, psychological trauma, urinary tract infection, vaginal discharge, vertigo and weight increased to be related to essure.The reporter commented: discrepancy noted in insertion date- (b)(6) 2013, (b)(6) 2013.The patient received treatment for menorrhagia, psychological trauma, fatigue, weight increased.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2013: bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-aug-2019: plaintiff fact sheet received : incident category updated.Event ¿ injury¿ was replaced with events given in the sd.Events added- pelvic pain, abdominal pain, dysmenorrhoea, menorrhagia, vertigo, psychological trauma, bladder disorder, urinary tract infection, fatigue, weight increased, cystitis, vaginal discharge.Outcome of event menorrhagia taken as ¿recovered / resolved¿.Removal date added.Insertion date updated.Reporter information, patient details , product indication updated.Lab data added.Incident no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records information become available from our investigation, this will be and other non-conformances data; should any new and reportable 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: 9002146
• MDR Text Key: 162052004
• Report Number: 2951250-2019-06192
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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: 08/30/2019
• Was Device Evaluated by Manufacturer?: No
• 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