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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hair Loss (1877); Pain (1994); Tinnitus (2103); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Arthralgia (2355); Depression (2361)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(4) on 25-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and cholecystectomy ("gallbladder resection") in a female patient who had essure (batch no.50512923) 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), cholecystectomy (seriousness criterion medically significant), alopecia ("alopecia"), arthralgia ("joint pain"), periostitis ("periostitis"), tinnitus ("tinnitus"), visual impairment ("vision decreased"), vaginal odour ("bad smell on vagina") and depression ("depression").The patient will be treated with surgery (surgery planned to remove essure).At the time of the report, the pelvic pain, cholecystectomy, alopecia, arthralgia, periostitis, tinnitus, visual impairment, vaginal odour and depression outcome was unknown.The reporter provided no causality assessment for alopecia, arthralgia, cholecystectomy, depression, pelvic pain, periostitis, tinnitus, vaginal odour and visual impairment with essure.The reporter commented: surgery for essure removal was planned (date not provided).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 (b)(6) 2017 for the following meddra preferred term: pelvic pain -analysis in the global safety database revealed 3592 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 regulatory authority is not possible.Incident: at the time of reporting, 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 (b)(6) (reference number: (b)(4)) on 25-aug-2017.The most recent information was received on 28-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and cholecystectomy ("gallbladder resection") in a female patient who had essure (batch no.50512923) 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), cholecystectomy (seriousness criterion medically significant), alopecia ("alopecia"), arthralgia ("joint pain"), periostitis ("periostitis"), tinnitus ("tinnitus"), visual impairment ("vision decreased"), vaginal odour ("bad smell on vagina") and depression ("depression").The patient was treated with surgery (surgery planned to remove essure).At the time of the report, the pelvic pain, cholecystectomy, alopecia, arthralgia, periostitis, tinnitus, visual impairment, vaginal odour and depression outcome was unknown.The reporter provided no causality assessment for alopecia, arthralgia, cholecystectomy, depression, pelvic pain, periostitis, tinnitus, vaginal odour and visual impairment with essure.The reporter commented: surgery for essure removal was planned (date not provided).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 29-sep-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 4.522 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.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 28-sep-2017: quality safety evaluation of ptc.Incident: at the time of reporting, 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 07981-0915
• MDR Report Key: 6857651
• MDR Text Key: 85780155
• Report Number: 2951250-2017-03577
• 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,Followup
• Report Date: 10/27/2017

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
• Device Lot Number: 50512923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention