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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Hair Loss (1877); Menstrual Irregularities (1959); Muscle Weakness (1967); Pain (1994); Rash (2033); Tinnitus (2103); Myalgia (2238); Arthralgia (2355); Numbness (2415); Vitamin Deficiency (4497)

Event Date 02/10/2011

Event Type  Injury  

Event Description

After receiving the implants, i began to have heavy menstrual cycles, unexplained rashes, joint pain, hair loss, ringing in the ears, back pain, hip pain, muscle pain and weakness, numbness and pain in thigh, painful skin on legs, vitamin d deficiency, pcos and osteoarthritis.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: 13358721
• MDR Text Key: 284544800
• Report Number: MW5106984
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ESS305
• Device Lot Number: 705317
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White