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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Fatigue (1849); Vitreous Floaters (1866); Hair Loss (1877); Incontinence (1928); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Tinnitus (2103); Anxiety (2328); Arthralgia (2355); Sweating (2444); Palpitations (2467); Weight Changes (2607)

Event Date 12/01/2007

Event Type  Injury  

Event Description

Ongoing issues since implantation in (b)(6) 2007.Heart palpitation, pmdd, amenorrhea, hair loss, fatigue, headaches, arm numbness, joint pain, weight gain, lack of period, memory issues, dry skin, excessive sweating, floaters in eyes, hair growth in new places, anemia, anxiety, ringing in ears, abdominal spasms, heart burn, loss of libido, bleeding after sex, painful intercourse, incontinence, abnormal menses, cervical dysplasia.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8213504
• MDR Text Key: 132269820
• Report Number: MW5082798
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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): Disability
• Patient Age: 39 YR
• Patient Weight: 113