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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hair Loss (1877); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Foreign Body In Patient (2687)

Event Date 12/27/2018

Event Type  Injury  

Event Description

Was implanted with essure more than 10 years ago.The past 2-3 years i have had many pains (back, hands, pelvis), hair loss, rashes, memory loss.Dr found that essure has migrated to uterine wall.Had full hysterectomy on (b)(6) 2018.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8212498
• MDR Text Key: 132204367
• Report Number: MW5082759
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• 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: 12/30/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 58