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 Dehydration (1807); Emotional Changes (1831); Fatigue (1849); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Neck Pain (2433); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("haemorrhagic menstrual periods") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria hospitalization and intervention required), dry skin ("dehydrated skin"), fatigue ("strong fatigue"), abdominal pain upper ("stomach pain"), gastrointestinal pain ("intestinal pain"), musculoskeletal pain ("shoulders pain"), neck pain ("neck pain"), weight increased ("weight gain"), mood swings ("mood swing"), memory impairment ("memory disorder"), nervous system disorder ("neurologic disorder") and ocular discomfort ("eyes tightness").At the time of the report, the menorrhagia, dry skin, fatigue, abdominal pain upper, gastrointestinal pain, musculoskeletal pain, neck pain, weight increased, mood swings, memory impairment, nervous system disorder and ocular discomfort outcome was unknown.The reporter provided no causality assessment for abdominal pain upper, dry skin, fatigue, gastrointestinal pain, memory impairment, menorrhagia, mood swings, musculoskeletal pain, neck pain, nervous system disorder, ocular discomfort and weight increased with essure.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 25-apr-2018 for the following meddra preferred term: menorrhagia.The analysis in the global safety database revealed 917 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 this meddra pt.Further company follow-up with the consumer or non-health professional is not possible.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: 7462300
• MDR Text Key: 106582796
• Report Number: 2951250-2018-01957
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

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: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 04/25/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 43 YR