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 Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Myalgia (2238); Arthralgia (2355)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (fda, reference number: mw5077432) on 07-jun-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant, life threatening and intervention required), headache ("headache on the right side"), back pain ("low back pain that radiated around right hip / upper back pain"), musculoskeletal pain ("pain in shoulder"), inflammation ("feeling inflamed"), feeling abnormal ("brain fog / feeling as my body was being attacked"), arthralgia ("pain in joints"), dysmenorrhoea ("painful periods") and menstruation irregular ("irregular periods").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, headache, back pain, musculoskeletal pain, inflammation, feeling abnormal, arthralgia, dysmenorrhoea and menstruation irregular outcome was unknown.The reporter considered arthralgia, back pain, dysmenorrhoea, feeling abnormal, headache, inflammation, menstruation irregular, musculoskeletal pain and pelvic pain to be related to essure.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.

Manufacturer Narrative

This case was initially received via regulatory authority (fda, reference number: mw5077432) on 07-jun-2018.The most recent information was received on 25-mar-2019.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant, life threatening and intervention required), headache ("headache on the right side"), back pain ("low back pain that radiated around right hip / upper back pain"), musculoskeletal pain ("pain in shoulder"), inflammation ("feeling inflamed"), feeling abnormal ("brain fog / feeling as my body was being attacked"), arthralgia ("pain in joints"), dysmenorrhoea ("painful periods") and menstruation irregular ("irregular periods").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, headache, back pain, musculoskeletal pain, inflammation, feeling abnormal, arthralgia, dysmenorrhoea and menstruation irregular outcome was unknown.The reporter considered arthralgia, back pain, dysmenorrhoea, feeling abnormal, headache, inflammation, menstruation irregular, musculoskeletal pain and pelvic pain to be related to essure.The reporter commented: an injury (disability) was mentioned but not specified and /or assigned to one of the events.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-mar-2019: quality-safety evaluation of ptc.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
• MDR Report Key: 7624158
• MDR Text Key: 111834717
• Report Number: 2951250-2018-02720
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention