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

Model Number ESS305

Device Problems Difficult to Remove (1528); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(6)) on 19-oct-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of pain ("pain all over the body") in an adult female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("partial removal of the essure" on (b)(6) 2018).There was no information on the patient's medical history or concurrent conditions.Essure was removed on (b)(6) 2018.On an unknown date, the patient had essure inserted.On unknown dates she became bedridden ("unable to get up"), experienced pain (seriousness criteria medically important and intervention required), headache ("headache"), dizziness ("dizziness") and adverse event ("the body of an old person, among other things") and was found to have serum ferritin increased ("high ferritin level").The patient was treated with surgery (essure removal).At the time of the report, none of the events had resolved.No causality assessment was received for essure with regard to pain, headache, dizziness, serum ferritin increased, bedridden or adverse event.The reporter commented: the events occurred several years after the insertion of the essure implants and even more symptoms after the partial removal, the symptoms are still present.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

The below report was received by health authority ansm (reference number: (b)(4)) on 19-oct-2023.The most recent information was received on 07-nov-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of pain ("pain all over the body") in an adult female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: contraceptive device removal incomplete ("partial removal of the essure" on (b)(6) 2018).There was no information on the patient's medical history or concurrent conditions.Essure was removed on 14-feb-2018.On an unknown date, the patient had essure inserted.On unknown dates she experienced pain (seriousness criteria medically important and intervention required), mobility decreased ("unable to get up"), headache ("headache"), dizziness ("dizziness") and adverse event ("the body of an old person, among other things") and was found to have serum ferritin increased ("high ferritin level").The patient was treated with surgery (essure removal).At the time of the report, none of the events had resolved.No causality assessment was received for essure with regard to pain, headache, dizziness, serum ferritin increased, mobility decreased or adverse event.The reporter commented: the events occurred several years after the insertion of the essure implants and even more symptoms after the partial removal, the symptoms are still present.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: 07-nov-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.

• 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: 18005510
• MDR Text Key: 326520655
• Report Number: 2951250-2023-03144
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• 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: 11/07/2023
• 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; Other
• Patient Sex: Female