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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

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.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("metalic fragments were still inside her (2mm)").There was no information on the patient's medical history or concurrent conditions.In 2016, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), dysmenorrhoea ("dysmenorrhea") and feeling abnormal ("feeling of retrosternal pressure at night").The patient was treated with surgery (salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered dysmenorrhoea, feeling abnormal, genital haemorrhage, pelvic pain and swelling to be related to essure administration.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

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.Other product or product use issues identified: complication of device removal "metalic fragments were still inside her (2mm)".In 2016, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), dysmenorrhoea ("dysmenorrhea") and chest discomfort ("feeling of retrosternal pressure at night").The patient was treated with surgery (salpingectomy).Essure was removed on 10-jan-2019.At the time of the report, the pelvic pain, swelling, genital haemorrhage, dysmenorrhoea and chest discomfort outcome was unknown.The reporter considered chest discomfort, dysmenorrhoea, genital haemorrhage, pelvic pain and swelling to be related to essure.Amendment: the report was amended for the following reason: coding request received.Description to be coded was changed from abnormal feeling (whole body) to retrosternal pressure.No new follow-up information was received from the reporter.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and device breakage ("metalic fragments were still inside her (2mm)") in a female patient who had essure inserted.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("metalic fragments were still inside her (2mm)").There was no information on the patient's medical history or concurrent conditions.In 2016, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), dysmenorrhoea ("dysmenorrhea") and chest discomfort ("feeling of retrosternal pressure at night").The patient was treated with surgery (salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered chest discomfort, device breakage, dysmenorrhoea, genital haemorrhage, pelvic pain and swelling to be related to essure administration.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 15-aug-2022: quality safety evaluation of product technical complaint; event "metalic fragments were still inside her (2mm)" was split into device breakage and device removal incomplete.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ('pelvic pain') and device breakage ('metalic fragments were still inside her (2mm)') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "metalic fragments were still inside her (2mm)".In 2016, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), dysmenorrhoea ("dysmenorrhea") and chest discomfort ("feeling of retrosternal pressure at night").The patient was treated with surgery (salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, device breakage, swelling, genital haemorrhage, dysmenorrhoea and chest discomfort outcome was unknown.The reporter considered chest discomfort, device breakage, dysmenorrhoea, genital haemorrhage, pelvic pain and swelling to be related to essure.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 22-aug-2022: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer, and describes the occurrence of pelvic pain ("pelvic pain") and device breakage ("metalic fragments were still inside her (2mm)").In a female patient who had essure inserted.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2016, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later, she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), dysmenorrhoea ("dysmenorrhea"), chest discomfort ("feeling of retrosternal pressure at night").And complication of device removal ("metalic fragments were still inside her (2mm)").The patient was treated with surgery (salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered, chest discomfort, complication of device removal, device breakage, dysmenorrhoea, genital haemorrhage, pelvic pain and swelling to be related to essure administration.Quality safety evaluation of ptc: for essure, no defect could be confirmed, by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed, with regard to the reported complaint reason.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 22-aug-2022, quality safety evaluation of ptc.26-aug-2022, no new information updated.All required attempt were completed.Case routing completed.19-jan-2023, no new information updated.Based on the available information.A review of our complaint records and other relevant data was conducted.Any new and reportable information that becomes available from our investigation, will be 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
• 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
• MDR Report Key: 14701225
• MDR Text Key: 294858386
• Report Number: 2951250-2022-00640
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2022
• 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): Required Intervention; Other
• Patient Sex: Female