MAUDE Adverse Event Report: BAYER ESSURE PERMANENT CONTRACEPTIVE DISEASE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Fatigue (1849); Flatus (1865); Pain (1994); Cramp(s) (2193); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Date 05/15/2009

Event Type  Injury  

Event Description

Heavy bleeding, chronic pelvic pain, weakness, fatigue, brain fog, anemia, joint pain, forgetfulness, heavy periods lasting over 15 days, bloating cramping.

• Brand Name: ESSURE PERMANENT CONTRACEPTIVE DISEASE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7442599
• MDR Text Key: 106064890
• Report Number: MW5076547
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/17/2018

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 73