MAUDE Adverse Event Report: CONCEPTUS/BAYER ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Scar Tissue (2060)

Event Date 09/22/2020

Event Type  Injury  

Event Description

I had essure implanted in (b)(6) 2007.I had the follow up testing that showed one side was closed off with scar tissue, the other was not.The dr.Did not suggest removal, just another form of birth control.In 2015, the same dr.Removed polyps and a tumor from my uterus, never said that this was related to essure, or mentioned the coil that did not properly seal the fallopian tube.Ongoing bleeding issues resulted in my seeing another ob/gyn who did a hysterectomy, leaving my ovaries on (b)(6) 2020.One coil was appropriately in the fallopian tube, the other coil was not in the fallopian tube, cervix or uterus, radiology came to the operating room, and the coil was located, it had migrated to, and attached to, my small intestines.It was successfully removed, and i am now recovering.Fda safety report id# (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): CONCEPTUS/BAYER
• MDR Report Key: 10612753
• MDR Text Key: 209553987
• Report Number: MW5096974
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ESS305
• Device Lot Number: 625976
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 91