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 reported by a lawyer and describes the occurrence of abdominal pain ('severe (chronic) pain in the abdomen') in a female patient who had essure (batch no.A04531) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), arthralgia ("hips pain"), headache ("head pain"), fatigue ("extreme and chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), menstrual disorder ("menstrual cycle changed"), abnormal uterine bleeding ("abnormally heavy bleeding"), hypersensitivity ("allergic reactions") and mood swings ("mood swings") and was found to have hormone level abnormal ("hormonal problems").The patient was treated with surgery (essure removal with removal of fallopian tubes).Essure was removed.At the time of the report, the abdominal pain, back pain, arthralgia, headache, fatigue, amnesia, disturbance in attention, menstrual disorder, abnormal uterine bleeding, hormone level abnormal, hypersensitivity and mood swings outcome was unknown.The reporter provided no causality assessment for abnormal uterine bleeding, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, hormone level abnormal, hypersensitivity, menstrual disorder and mood swings with essure.The reporter considered abdominal pain to be related to essure.Lot number: a04531.Manufacturing date: 2012-05.Expiration date: 2015-05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2022: adverse event "injured person to claim damages" changed to "severe (chronic) pain in the abdomen"; also "back pain", "hips pain", "head pain", "extreme and chronic fatigue", "memory loss", "concentration problems", "menstrual cycle changed", "abnormally heavy bleeding", "hormonal problems", "allergic reactions", "mood swings" added to the case; reporter added; removal information added 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 reported by a lawyer and describes the occurrence of abdominal pain ('severe (chronic) pain in the abdomen') in a female patient who had essure (batch no.A04531) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), arthralgia ("hips pain"), headache ("head pain"), fatigue ("extreme and chronic fatigue"), amnesia ("memory loss"), disturbance in attention ("concentration problems"), menstrual disorder ("menstrual cycle changed"), abnormal uterine bleeding ("abnormally heavy bleeding"), hypersensitivity ("allergic reactions") and mood swings ("mood swings") and was found to have hormone level abnormal ("hormonal problems").The patient was treated with surgery (essure removal with removal of fallopian tubes).Essure was removed.At the time of the report, the abdominal pain, back pain, arthralgia, headache, fatigue, amnesia, disturbance in attention, menstrual disorder, abnormal uterine bleeding, hormone level abnormal, hypersensitivity and mood swings outcome was unknown.The reporter provided no causality assessment for abnormal uterine bleeding, amnesia, arthralgia, back pain, disturbance in attention, fatigue, headache, hormone level abnormal, hypersensitivity, menstrual disorder and mood swings with essure.The reporter considered abdominal pain to be related to essure.Lot number: a04531 manufacturing date: 2012-05 expiration date: 2015-05.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 18-mar-2022: quality safety evaluation of ptc.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: 13801708
• MDR Text Key: 290545957
• Report Number: 2951250-2022-00263
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: ESS305
• Device Lot Number: A04531
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2022
• Date Device Manufactured: 05/01/2012
• 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): Required Intervention; Other
• Patient Sex: Female