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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Intermenstrual Bleeding (2665); Heavier Menses (2666); Genital Bleeding (4507)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), iron deficiency anaemia ("anemia secondary to menorrhagia") and device dislocation ("hysteroscope showed that the patient having essure, only one side seen").The patient was treated with surgery (endometrial ablation).At the time of the report, the menorrhagia, iron deficiency anaemia and device dislocation outcome was unknown.The reporter considered device dislocation, iron deficiency anaemia and menorrhagia to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.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 menorrhagia ('menorrhagia') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), iron deficiency anaemia ("anemia secondary to menorrhagia") and device dislocation ("hysteroscope showed that the patient having essure, only one side seen").The patient was treated with surgery (endometrial ablation).At the time of the report, the menorrhagia, iron deficiency anaemia and device dislocation outcome was unknown.The reporter considered device dislocation, iron deficiency anaemia and menorrhagia to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of heavy menstrual bleeding ('menorrhagia') in an adult female patient who had essure (batch no.860784) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included human papilloma virus infection.Concomitant products included medroxyprogesterone acetate (depo-provera).On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced heavy menstrual bleeding (seriousness criteria medically significant and intervention required), iron deficiency anaemia ("anemia secondary to menorrhagia") and device dislocation ("hysteroscope showed that the patient having essure, only one side seen").The patient was treated with surgery (novasure endometrial ablation).At the time of the report, the heavy menstrual bleeding, iron deficiency anaemia and device dislocation outcome was unknown.The reporter considered device dislocation, heavy menstrual bleeding and iron deficiency anaemia to be related to essure.The reporter commented: insertion details-4 coils seen on the right and three coils seen on the left ostium.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-jul-2021: mr received-lot number added.New reporter, lab data, medical history, insertion details, concomitant durg were added.We received a lot number in this case.A technical investigation will be 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
• MDR Report Key: 10496875
• MDR Text Key: 206107595
• Report Number: 2951250-2020-13843
• 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,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 860784
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 09/14/2020; 07/01/2021
• Supplement Dates FDA Received: 09/14/2020; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA
• Patient Outcome(s): Other; Required Intervention