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

Model Number ESS305

Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of abdominal pain ("severe (chronic) pain in the abdomen") in a female patient who had essure inserted (lot no.A57110).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.An unknown time later she experienced abdominal pain (seriousness criteria medically important and intervention required), back pain ("back pain"), arthralgia ("hip pain"), headache ("head pain"), fatigue ("extreme and chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), heavy menstrual bleeding ("abnormally heavy blood loss") and hypersensitivity ("allergic reaction") 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, all of the events had resolved.The reporter considered abdominal pain, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, heavy menstrual bleeding, hormone level abnormal and hypersensitivity to be related to essure administration.Lot number:a57110 manufacturing date: 2012-09 expiration date: 2015-09.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: (b)(6) 2022: summons received.Event: adverse events nos updated to events: severe (chronic) pain in the abdomen, back, hips and/or head, extreme and chronic fatigue, memory loss, concentration problems, abnormally heavy blood loss, hormonal problems, allergic reactions.Case become valid and serious incident.Action taken with drug added.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 and describes the occurrence of abdominal pain ("severe (chronic) pain in the abdomen") in a female patient who had essure inserted (lot no.A57110).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.An unknown time later she experienced abdominal pain (seriousness criteria medically important and intervention required), back pain ("back pain"), arthralgia ("hip pain"), headache ("head pain"), fatigue ("extreme and chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), heavy menstrual bleeding ("abnormally heavy blood loss") and hypersensitivity ("allergic reaction") 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, all of the events had resolved.The reporter considered abdominal pain, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, heavy menstrual bleeding, hormone level abnormal and hypersensitivity to be related to essure administration.Lot number: a57110, manufacturing date: 2012-09, and expiration date: 2015-09.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: 03-oct-2022: quality safety evaluation of product technical complaint.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.

• 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: 15508872
• MDR Text Key: 300872601
• Report Number: 2951250-2022-01119
• 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
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: ESS305
• Device Lot Number: A57110
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2022
• Date Device Manufactured: 09/01/2012
• 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