MAUDE Adverse Event Report: CONCEPTUS, INC/BAYER ESSURE

Model Number ESS305

Device Problem Misfire (2532)

Patient Problems Cyst(s) (1800); Pyrosis/Heartburn (1883); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Burning Sensation (2146); Tingling (2171); Complaint, Ill-Defined (2331); Abdominal Distention (2601); Weight Changes (2607)

Event Type  Injury  

Event Description

I had essure implanted in my left fallopian tube on (b)(6) 2012.I had adiana implanted on (b)(6) 2012, but it misfired on the left side and the doctor couldn't find another adiana device to use because it was discontinued.Problems i've experienced since implantation: ovarian cysts, painful ovulation, chronic pelvic pain, severe bloating, heartburn, bowel issues, bladder sensitivity, tingling sensations i limbs, diminished brain function, sensation of burning/prickling/itching of skin, blood sugar issue, heightened allergies, weight gain, hair changes, joint pian, unsteadiness/balance issues, gum sensitivity, insomnia.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): CONCEPTUS, INC/BAYER
• MDR Report Key: 5656251
• MDR Text Key: 45364909
• Report Number: MW5062247
• Device Sequence Number: 1
• Product Code: HHS
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ESS305
• Device Lot Number: 910511
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability