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

Model Number ESS205

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Diarrhea (1811); Pain (1994); Disability (2371)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (aemps, reference number: (b)(4)) on 28-mar-2018.This spontaneous case was reported by a consumer and describes the occurrence of back pain ("pains in back"), pelvic pain ("pain in pelvis"), irritable bowel syndrome ("irritable bowel") and diarrhoea ("diarrheas") in a female patient who had essure (ess205) inserted.In 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced back pain (seriousness criteria disability and intervention required), pelvic pain (seriousness criteria disability and intervention required), irritable bowel syndrome (seriousness criterion disability) and diarrhoea (seriousness criterion disability).The patient was treated with surgery (essure was removed in (b)(6) 2017).Essure (ess205) was removed in (b)(6) 2017.At the time of the report, the back pain, pelvic pain, irritable bowel syndrome and diarrhoea had resolved.The reporter considered back pain, diarrhoea, irritable bowel syndrome and pelvic pain to be related to essure (ess205).The reporter commented: she visited psychologists due to disability caused by all of symptoms that impeded her to have her daily routine, even she had to leave her work, as she could not manage it as she is an independent person.Diagnostic results: unspecified date - digestive tests were performed: normal.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred terms: back pain.The analysis in the global safety database revealed 502 cases.Pelvic pain.The analysis in the global safety database revealed 10.493 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.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
• MDR Report Key: 7390115
• MDR Text Key: 104140025
• Report Number: 2951250-2018-01395
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial
• Report Date: 04/02/2018

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: ESS205
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/02/2018
• 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): Required Intervention; Disability