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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anemia (1706)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of iron deficiency anaemia ('anemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced iron deficiency anaemia (seriousness criteria medically significant and intervention required), pelvic pain ("years of pain, extremely painful cramps"), menorrhagia ("acute heavy periods"), dizziness ("recurrent dizziness") and back pain ("back pain").The patient was treated with red blood cells and red blood cells.Essure treatment was not changed.At the time of the report, the iron deficiency anaemia outcome was unknown and the pelvic pain, menorrhagia, dizziness and back pain had not resolved.The reporter considered back pain, dizziness, iron deficiency anaemia, menorrhagia and pelvic pain to be related to essure.The reporter commented: essure was inserted in usa in 2013, events started there.She also visited doctors in the usa.Since summer 2020, consumer is back in (b)(6).Gynecologist recommended essure removal.Consumer requests reimbursement quality-safety evaluation of ptc: unable to confirm complaint.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

This spontaneous case was reported by a consumer and describes the occurrence of iron deficiency anaemia ('anemia') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced iron deficiency anaemia (seriousness criteria medically significant and intervention required), pelvic pain ("years of pain, extremely painful cramps"), menorrhagia ("acute heavy periods"), dizziness ("recurrent dizziness") and back pain ("back pain").The patient was treated with red blood cells and red blood cells.Essure treatment was not changed.At the time of the report, the iron deficiency anaemia outcome was unknown and the pelvic pain, menorrhagia, dizziness and back pain had not resolved.The reporter considered back pain, dizziness, iron deficiency anaemia, menorrhagia and pelvic pain to be related to essure.The reporter commented: essure was inserted in usa in 2013, events started there.She also visited doctors in the usa.Since summer 2020, consumer is back in germany.Gynecologist recommended essure removal.Consumer requests reimbursement 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 26-feb-2021: quality-safety evaluation of ptc.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 11377288
• MDR Text Key: 233546226
• Report Number: 2951250-2021-00574
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention