MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 04/16/2015

Event Type  Injury  

Event Description

(b)(6) 2012, (b)(6) essure, (b)(6) 2013, (b)(6) uterine ablation for severe bleeding, several hospital visits and ultrasounds later, (b)(6) 2015, (b)(6) hysterectomy, 2 days ago another er visit with x-rays showing the intense flank pain was site of coil on left, right coil not found in x-ray.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4724220
• MDR Text Key: 5750660
• Report Number: MW5042200
• 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: 04/16/2015

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: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR
• Patient Weight: 64