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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("the foreign-body material has been removed") in a female patient who had essure inserted (lot no.A82464-invalid).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 underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: discrepancy start date (b)(6) 2014.Lot number a82464 is invalid.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 04-aug-2022: consumer's name updated, essure start date updated from (b)(6) 2014, previous non-serious event injury was updated to the foreign-body material has been removed, seriousness of the case was upgraded from non-serious to serious-incident.We received an invalid 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 reported by a lawyer and describes the occurrence of medical device removal ('the foreign-body material has been removed') in a female patient who had essure (batch no.A82464-invalid) inserted.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.The reporter commented: discrepancy start date: (b)(6) 2014 or (b)(6) 2014.Lot number a82464 is invalid.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 11-aug-2022: quality safety evaluation of product technical complaint.On 9-aug-2022: ha reference number added.We received an invalid 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 and describes the occurrence of abdominal pain ("(chronic) pain in the abdomen") in a female patient who had essure inserted (lot no.A82464-invalid).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 abdominal pain (seriousness criterion intervention required), back pain ("(chronic) pain in the back"), arthralgia ("(chronic) pain in the hips"), headache ("(chronic) pain in the head"), fatigue ("chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), heavy menstrual bleeding ("change in their menstrual cycle( abnormally heavy blood loss)"), hypersensitivity ("allergic reaction") and premature menopause ("early menopause") and was found to have hormone level abnormal ("hormonal problems").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the abdominal pain, back pain, arthralgia, headache, fatigue, amnesia, disturbance in attention, heavy menstrual bleeding, hormone level abnormal and hypersensitivity had resolved.The outcome of premature menopause was unknown.The reporter considered abdominal pain, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, heavy menstrual bleeding, hormone level abnormal, hypersensitivity and premature menopause to be related to essure administration.The reporter commented: discrepancy start date (b)(6) 2014.Lot number a82464 is invalid.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: 03-feb-2023: event medical device removal updated to (chronic) pain in the abdomen, back, hips and/or head, extreme and chronic fatigue, memory loss, concentration problems, change in their menstrual cycle (abnormally heavy blood loss), hormonal problems, allergic reactions, early menopause.We received an invalid 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 and describes the occurrence of abdominal pain ("(chronic) pain in the abdomen") in a female patient who had essure inserted (lot no.A82464-invalid).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 abdominal pain (seriousness criterion intervention required), back pain ("(chronic) pain in the back"), arthralgia ("(chronic) pain in the hips"), headache ("(chronic) pain in the head"), fatigue ("chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), heavy menstrual bleeding ("change in their menstrual cycle( abnormally heavy blood loss)"), hypersensitivity ("allergic reaction") and premature menopause ("early menopause") and was found to have hormone level abnormal ("hormonal problems").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the abdominal pain, back pain, arthralgia, headache, fatigue, amnesia, disturbance in attention, heavy menstrual bleeding, hormone level abnormal and hypersensitivity had resolved.The outcome of premature menopause was unknown.The reporter considered abdominal pain, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, heavy menstrual bleeding, hormone level abnormal, hypersensitivity and premature menopause to be related to essure administration.The reporter commented: discrepancy start date: (b)(6) 2014.Lot number: a82464 is invalid.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: 16-feb-2023: quality safety evaluation of ptc.We received an invalid 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: 15176479
• MDR Text Key: 297351458
• Report Number: 2951250-2022-00962
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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: A82464-INVALID
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• 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