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 (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain") in an adult female patient who had essure inserted (lot no.B93874) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of dysmenorrhea, bloating, back pain, unilateral leg swelling, parity 3, multigravida and fibroids.On (b)(6)2014, the patient had essure inserted.Essure was removed on (b)(6)2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required) and genital haemorrhage ("bleeding").The patient was treated with surgery (bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered genital haemorrhage and pelvic pain to be related to essure administration.The reporter commented: both side 3 trailing coils.Insertion date discrepancy (b)(6)2014 as per mr.Lot number:b93874 manufacturing date: 2013/11 expiration date:2016/11.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 02-may-2023: reporter added, non drug treatment notes, reference section updated.Case category updated to serious incident.We received a lot number in this case.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 ("pain") in an adult female patient who had essure inserted (lot no.B93874) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of dysmenorrhea, bloating, back pain, unilateral leg swelling, parity 3, multigravida and fibroids.On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2021.An unknown time later she experienced pelvic pain (seriousness criterion intervention required) and genital haemorrhage ("bleeding").The patient was treated with surgery (bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered genital haemorrhage and pelvic pain to be related to essure administration.The reporter commented: both side 3 trailing coils.Insertion date discrepancy- (b)(6) 2014 as per mr.Lot number:b93874 manufacturing date: (b)(6) 2013 expiration date: (b)(6) 2016.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: (b)(6) 2023: quality safety evaluation of ptc.We received a lot number in this case.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: 16996040
• MDR Text Key: 315876847
• Report Number: 2951250-2023-02435
• 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
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: ESS305
• Device Lot Number: B93874
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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): Required Intervention
• Patient Sex: Female