MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Lot Number A96180

Device Problem Material Fragmentation (1261)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Weight Changes (2607)

Event Type  Injury  

Event Description

I had essure done for permanent birth control.After a while i developed pain, heavy periods and weight gain.I had it removed (b)(6) 2019.It had migrated from one fallopian tub to uterine wall.I continued to have pain.I recently had an ultrasound and broken pieces were found in uterine wall.I had a hysterectomy (b)(6) 2021 where pieces of broken coils were found in uterine wall with injury and scars.Fda safety report id# (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 11938355
• MDR Text Key: 254543923
• Report Number: MW5101699
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: A96180
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 116