MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Menstrual Irregularities (1959); Perforation (2001); Cramp(s) (2193); Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2014

Event Type  Injury  

Event Description

(b)(4).For two days after implantation i had severe cramping, which eventually went away.Afterward my periods changed drastically, going from 5-7 days every 29 days to 21 days every 45 days.My doctor attributed this to depo provera.On (b)(6) 2015 i had my hysterosalpingogram performed.My right essure went completely to the end of my fallopian tube but shown as blocked.My left essure appeared to have perforated my tube and was shown as unblocked.My doctor advised me that i would need to take birth control to prevent pregnancy.I refused and requested to still be sterilized.On (b)(6) 2015 i had a bilateral salpingetomy.My surgeon reported to me that my left essure perforated my uterus and was left inside.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4921729
• MDR Text Key: 6051662
• Report Number: MW5044233
• 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
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2015

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: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2015
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA, VALIUM, HYDROCODONE, IBUPROFEN
• Patient Outcome(s): Other
• Patient Age: 35.000 YR