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 Diarrhea (1811); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144); Weight Changes (2607)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority fda (reference number: mw5071005) on 31-jul-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and genital haemorrhage ("heavy bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included bupropion (wellbutrin), duloxetine hydrochloride (cymbalta), multivitamin and trazodone.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria disability and intervention required), genital haemorrhage (seriousness criterion medically significant), vomiting ("severe vomiting"), diarrhoea ("diarrhea"), weight decreased ("rapid weight loss") and fibroma ("fibroid tumors").The patient was treated with surgery (currently scheduling a hysterectomy to completely remove the devices).Essure treatment was not changed.At the time of the report, the pelvic pain, genital haemorrhage, vomiting, diarrhoea, weight decreased and fibroma had not resolved.The reporter considered diarrhoea, fibroma, genital haemorrhage, pelvic pain, vomiting and weight decreased to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Incident.No lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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 07981-0915
• MDR Report Key: 6795066
• MDR Text Key: 82715919
• Report Number: 2951250-2017-02936
• Device Sequence Number: 1
• Product Code: HHS
• 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: 08/15/2017

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/15/2017
• 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: CYMBALTA (DULOXETINE HYDROCHLORIDE); MULTIVITAMIN (MULTIVITAMIN); TRAZODONE (TRAZODONE); WELLBUTRIN (BUPROPION)
• Patient Outcome(s): Other; Required Intervention; Disability