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

Model Number ESSURE REF ESS305

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

Patient Problems Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Dizziness (2194)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Memory loss, loss of sight, joint pain muscle, major bleeding, overwhelming fatigue, dizziness, anemia.

• Brand Name: ESSURE IMPLANT
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 8372046
• MDR Text Key: 137361943
• Report Number: MW5084408
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ESSURE REF ESS305
• Device Lot Number: C26960
• 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): Life Threatening; Disability
• Patient Age: 50 YR
• Patient Weight: 49