MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 06/19/2017

Event Type  Injury  

Event Description

(b)(4).I had the procedure and they were unable to place essure in my right tube and had difficulty with the left side but eventually got it in.After i returned home i started experiencing extreme pain in my left lower abdomen and down my left leg.The next day my pain was still high and i began to bleed.I am still in pain.My doctor prescribed pain meds and ibuprofen after an emergency room (er) visit where they told me they couldn't help.The side effects are continuing still and.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6889991
• MDR Text Key: 87198801
• Report Number: MW5072358
• 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: 06/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• 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: LISINOPRIL , ALBUTEROL
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 32.000 YR