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 Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Anxiety (2328); Depression (2361); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in a female patient who had essure (batch no.Css079) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: clotrimazole, cytotec and flexeril.Concurrent conditions included cervical dysplasia, horseshoe kidney, urination difficulty, paratubal cyst, left lower quadrant pain, cervix neoplasm stage iii, ovarian cyst and hepatic steatosis.Concomitant products included medroxyprogesterone acetate (depo provera).On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysgeusia ("metallic taste in mouth"), anxiety ("anxiety"), feeling abnormal ("brain fog"), depression ("depression"), dysmenorrhoea ("dysmenorrhea (cramping)") and allergy to metals ("nickel allergy") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy (lavh), bilateral salpingectomy, cystoscopy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, dysgeusia, anxiety, feeling abnormal, depression, dysmenorrhoea, allergy to metals, weight increased and weight decreased outcome was unknown.The reporter considered allergy to metals, anxiety, depression, dysgeusia, dysmenorrhoea, feeling abnormal, pelvic pain, weight decreased and weight increased to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-may-2019: plaintiff fact sheet and medical records were received.Events per pfs: pain, metallic taste in mouth, anxiety, brain fog, depression, dysmenorrhea (cramping), nickel allergy, weight gain and weight loss.Medical history, concurrent condition, concomitant medication and lot number were added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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: 8656989
• MDR Text Key: 146625319
• Report Number: 2951250-2019-02327
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2019

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 Model Number: ESS305
• Device Lot Number: CSS079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 05/31/2019
• 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
• Treatment: DEPO PROVERA
• Patient Outcome(s): Other; Required Intervention