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

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

Patient Problems Flatus (1865); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Paralysis (1997); Sensitivity of Teeth (2427); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of back pain ("lumbodorsal pain") and hemiparesis ("hemiparesis on right side of the body after removal") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), hemiparesis (seriousness criterion medically significant), flatulence ("meteorism"), menorrhagia ("menorrhagia"), asthenia ("asthenia"), headache ("helmet headaches"), memory impairment ("memory disorders"), toothache ("pain in dental amalgam"), rotator cuff syndrome ("tendonitis in shoulder"), migraine ("sudden migraines after removal"), tremor ("hemiparesis and sequela of trembling on right side of the body after removal") and facial pain ("bilateral facial pain").On an unknown date, the patient experienced alopecia, eczema and musculoskeletal pain.The patient was treated with surgery (salpingectomy via laparoscopy).Essure was removed.At the time of the report, the back pain, hemiparesis, flatulence, menorrhagia, asthenia, headache, memory impairment, toothache, rotator cuff syndrome, migraine, tremor and facial pain outcome was unknown and the alopecia, eczema and musculoskeletal pain outcome was unknown.The reporter considered alopecia, asthenia, back pain, eczema, facial pain, flatulence, headache, hemiparesis, memory impairment, menorrhagia, migraine, musculoskeletal pain, rotator cuff syndrome, toothache and tremor to be related to essure.The reporter commented: no further information was expected.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 term: back pain the analysis in the global safety database revealed 532 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 lawyer 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of back pain ("lumbodorsal pain") and hemiparesis ("hemiparesis on right side of the body after removal") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), hemiparesis (seriousness criterion medically significant), flatulence ("meteorism"), menorrhagia ("menorrhagia"), asthenia ("asthenia"), headache ("helmet headaches"), memory impairment ("memory disorders"), alopecia ("hair loss"), toothache ("pain in dental amalgam"), eczema ("eczema on face"), musculoskeletal pain ("musculoskeletal pain"), rotator cuff syndrome ("tendonitis in shoulder"), migraine ("sudden migraines after removal"), tremor ("hemiparesis and sequela of trembling on right side of the body after removal") and facial pain ("bilateral facial pain").The patient was treated with surgery (salpingectomy via laparoscopy).Essure was removed.At the time of the report, the back pain, hemiparesis, flatulence, menorrhagia, asthenia, headache, memory impairment, alopecia, toothache, eczema, musculoskeletal pain, rotator cuff syndrome, migraine, tremor and facial pain outcome was unknown.The reporter considered alopecia, asthenia, back pain, eczema, facial pain, flatulence, headache, hemiparesis, memory impairment, menorrhagia, migraine, musculoskeletal pain, rotator cuff syndrome, toothache and tremor to be related to essure.The reporter commented: no further information was expected.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 18-jul-2018: quality-safety evaluation of ptc.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: 7588714
• MDR Text Key: 110712904
• Report Number: 2951250-2018-02575
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention