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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("i've been in pain") in an adult female patient who had essure inserted for female sterilisation.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2017, the patient had essure inserted.Essure was removed on (b)(6) 2017.An unknown time later she experienced pelvic pain (seriousness criterion intervention required).The patient was treated with surgery (removal surgery).At the time of the report, the outcome of the event was unknown.The reporter considered pelvic pain to be related to essure administration.Concerning the injuries reported in this case, the following ones was confirmed via social media: pelvic pain.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: 21-feb-2023: pif received.Reporter information, patient date of birth, product indication, start, stop dates, removal details, action taken with drug added.Pelvic pain marked as 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 ("i've been in pain") in an adult female patient who had essure inserted for female sterilisation.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2017, the patient had essure inserted.Essure was removed on (b)(6) 2017.An unknown time later she experienced pelvic pain (seriousness criterion intervention required).The patient was treated with surgery (removal surgery).At the time of the report, the outcome of the event was unknown.The reporter considered pelvic pain 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: 29-mar-2023: 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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("i've been in pain") in an adult female patient who had essure inserted for female sterilisation.The patient had a medical history of adenomyosis, chronic cervicitis, perineal pain, chronic pain and endometriosis.On (b)(6) 2017, the patient had essure inserted.Essure was removed on (b)(6) 2017.An unknown time later she experienced pelvic pain (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic assisted vaginal hysterectomy salpingectomy).At the time of the report, the outcome of the event was unknown.The reporter considered pelvic pain to be related to essure administration.The reporter commented: discrepancy noted: removal date: as per argus: (b)(6) 2017.As per mr: (b)(6) 2017.Diagnostic results (normal ranges are provided in parenthesis if available): [pathology test] on (b)(6) 2017: chronic cervicitis and immature squamous metaplasia.Adenomyosis.Serosal adhesions.Proliferative endometrium.No polyp, endometrial hyperplasia or carcinoma bilateral identified; fallopian tubes with no significant histopathologic abnormality.Peritoneal biopsy: vascular adhesion no endometriosis identified.Gross examination: specimen: uterus, cervix and bilateral tubes.Fallopian tube: unremarkable, no fimbriated and identified.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: 31-oct-2023: mr received: reporters information patient medical history and surgical pathology reports were added.Product removal date and rcc 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 16494405
• MDR Text Key: 310779048
• Report Number: 2951250-2023-00975
• 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
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• 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: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Female