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

Lot Number 646513

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Bruise/Contusion (1754); Headache (1880); Inflammation (1932); Pain (1994); Rash (2033); Myalgia (2238); Urticaria (2278); Arthralgia (2355); Tooth Fracture (2428); No Code Available (3191)

Event Date 09/30/2009

Event Type  Injury  

Event Description

After getting the birth control essure inserted in (b)(6) 2009, i've had health issues including pain in pelvic, legs, joints, muscles and face.I've had inflammation in all parts of my body.It's triggered auto immune diseases and all that comes with those: sores, hives, rashes, bruises, broken teeth, metal taste, trigeminal neuralgia, headaches, lung issues, intestinal problems.The list is long.

• Brand Name: ESSURE BIRTH CONTROL
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7757493
• MDR Text Key: 116555174
• Report Number: MW5078908
• Device Sequence Number: 0
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2012
• Device Lot Number: 646513
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 52 YR
• Patient Weight: 150