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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('random sharp pain/pain') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal distension ("bloating"), cystitis ("have been getting bladder infection"), polycystic ovaries ("pcos") and genital haemorrhage ("bleeding").The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the pelvic pain, abdominal distension, cystitis, polycystic ovaries and genital haemorrhage outcome was unknown.The reporter considered abdominal distension, cystitis, genital haemorrhage, pelvic pain and polycystic ovaries to be related to essure.The reporter commented: discrepancy noted in product removal date: (b)(6) 2022.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 15-jul-2022: pif received.Reporter information, patient date of birth, product indication, insertion date, removal details, event: bleeding, pcos, reporter causality comment added.Case become serious incident.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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("random sharp pain/pain") in a female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), abdominal distension ("bloating"), cystitis ("have been getting bladder infection"), polycystic ovaries ("pcos") and genital haemorrhage ("bleeding").The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, cystitis, genital haemorrhage, pelvic pain and polycystic ovaries to be related to essure administration.The reporter commented: discrepancy noted in product removal date: (b)(6) 2022.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: 29-jul-2022: quality safety evaluation of product technical complaint.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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("random sharp pain/pain") in a female patient who had essure inserted (lot no.B82476) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2020.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), abdominal distension ("bloating"), cystitis ("have been getting bladder infection"), polycystic ovaries ("pcos") and genital haemorrhage ("bleeding").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, cystitis, genital haemorrhage, pelvic pain and polycystic ovaries to be related to essure administration.The reporter commented: discrepancy noted in product removal date: (b)(6) 2022 discrepancy noted in date of birth: (b)(6) 1992 date of insertion updated from (b)(6) 2014 to (b)(6) 2014.Right: 5 coils; left: 1 coil.Lot number: b82476, manufacture date: 2013-10 and expiration date: 2016-10.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 05-dec-2022: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("random sharp pain/pain") in a female patient who had essure inserted (lot no.B82476) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2020.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), abdominal distension ("bloating"), cystitis ("have been getting bladder infection"), polycystic ovaries ("pcos") and genital haemorrhage ("bleeding").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, cystitis, genital haemorrhage, pelvic pain and polycystic ovaries to be related to essure administration.The reporter commented: discrepancy noted in product removal date: (b)(6) 2022.Discrepancy noted in date of birth: (b)(6) 1992.Date of insertion updated from (b)(6) 2014 to (b)(6) 2014.Right: 5 coils; left: 1 coil.Lot number: b82476.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: 11-nov-2022: medical records received.Reporter information, patient aka name, lot number, removal date added.Product insertion date updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: 15074117
• MDR Text Key: 296298151
• Report Number: 2951250-2022-00877
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: ESS305
• Device Lot Number: B82476
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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
• Patient Sex: Female