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

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Fatigue (1849); Flatus (1865); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Pain (1994); Blurred Vision (2137); Hot Flashes/Flushes (2153); Discomfort (2330); Arthralgia (2355); Numbness (2415); Chest Tightness/Pressure (2463); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pains in side") in a female patient who had essure inserted.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 pelvic pain (seriousness criteria medically significant and intervention required), flatulence ("gas lots"), vaginal flatulence ("vaginal gas"), back pain ("back pain"), feeling hot ("feeling on fire at times"), feeling abnormal ("brain fog can't remember common things"), fatigue ("tired all the times"), dysgeusia ("metal taste in mouth"), dyspepsia ("heartburn"), pain in extremity ("shooting"), vision blurred ("eyes get blurry"), arthralgia ("left hip pain/ hurt knee"), muscle spasms ("leg cramps"), nausea ("nauseous everyday"), muscular weakness ("trouble squeezing right hand fully-lack of strength"), balance disorder ("loss of balance fell again"), fall ("loss of balance fell again"), hypoaesthesia oral ("numbness in upper lip"), chest discomfort ("chest heaviness"), allergy to synthetic fabric ("clothing fabrics bothering over 2 years/mold issues") and pain ("pain in left side").The patient was treated with surgery (underwent surgery to remove essure).Essure was removed.At the time of the report, the pelvic pain, flatulence, vaginal flatulence, back pain, feeling hot, feeling abnormal, fatigue, dysgeusia, dyspepsia, pain in extremity, vision blurred, arthralgia, muscle spasms, nausea, muscular weakness, balance disorder, fall, hypoaesthesia oral, chest discomfort, allergy to synthetic fabric and pain outcome was unknown.The reporter considered allergy to synthetic fabric, arthralgia, back pain, balance disorder, chest discomfort, dysgeusia, dyspepsia, fall, fatigue, feeling abnormal, feeling hot, flatulence, hypoaesthesia oral, muscle spasms, muscular weakness, nausea, pain, pain in extremity, pelvic pain, vaginal flatulence and vision blurred to be related to essure.The reporter commented: cross referenced with case number: (b)(4).Diagnostic results: nickel and vit d testing performed.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

The spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pains in side") in a female patient who had essure inserted.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 pelvic pain (seriousness criteria medically significant and intervention required), flatulence ("gas lots"), vaginal flatulence ("vaginal gas"), back pain ("back pain"), feeling hot ("feeling on fire at times"), feeling abnormal ("brain fog can't remember common things"), fatigue ("tired all the times"), dysgeusia ("metal taste in mouth"), dyspepsia ("heartburn"), pain in extremity ("shooting"), vision blurred ("eyes get blurry"), arthralgia ("left hip pain/ hurt knee"), muscle spasms ("leg cramps"), nausea ("nauseous everyday"), muscular weakness ("trouble squeezing right hand fully-lack of strength"), balance disorder ("loss of balance fell again"), fall ("loss of balance fell again"), hypoaesthesia oral ("numbness in upper lip"), chest discomfort ("chest heaviness"), allergy to synthetic fabric ("clothing fabrics bothering over 2 years/mold issues") and pain ("pain in left side").The patient was treated with surgery (underwent surgery to remove essure).Essure was removed.At the time of the report, the pelvic pain, flatulence, vaginal flatulence, back pain, feeling hot, feeling abnormal, fatigue, dysgeusia, dyspepsia, pain in extremity, vision blurred, arthralgia, muscle spasms, nausea, muscular weakness, balance disorder, fall, hypoaesthesia oral, chest discomfort, allergy to synthetic fabric and pain outcome was unknown.The reporter considered allergy to synthetic fabric, arthralgia, back pain, balance disorder, chest discomfort, dysgeusia, dyspepsia, fall, fatigue, feeling abnormal, feeling hot, flatulence, hypoaesthesia oral, muscle spasms, muscular weakness, nausea, pain, pain in extremity, pelvic pain, vaginal flatulence and vision blurred to be related to essure.The reporter commented: cross referenced with case number : (b)(4).Diagnostic results: nickel and vit d testing performed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-nov-2018: quality safety evaluation of product technical complaints.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
• MDR Report Key: 7638354
• MDR Text Key: 112347784
• Report Number: 2951250-2018-02813
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention