MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hair Loss (1877); Irritation (1941); Pain (1994); Skin Irritation (2076); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Constipation (3274)

Event Date 01/01/2012

Event Type  Injury  

Event Description

(b)(4).After essure i had new: pelvic pain.Severe periods with huge clots.Body aches.Hair loss.Brain fog.Depression.Stabbing pain near my left tube.Weight gain.Belly/bloating.Constipation.Irritated skin.And it all ended with a full hysterectomy at (b)(6) yrs old.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5393796
• MDR Text Key: 36910599
• Report Number: MW5059633
• 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: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IBUPROFEN. KLONOPIN. ADVAIR. VENTOLIN.ESS
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 36.000 YR