MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Device Dislodged or Dislocated (2923); Extrusion (2934); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Death, Intrauterine Fetal (1855); Hemorrhage/Bleeding (1888); Rupture (2208); Pregnancy (3193)

Event Date 06/08/2015

Event Type  Death  

Event Description

(b)(4).I delivered a (b)(6) stillborn baby on (b)(6) 2015.I had the essure placed in (b)(6) 2013.The had an hsg that showed the essure did not properly form the scar tissue and my tube was still open.I started taking depot shots.I had no clue i was pregnant, until a few days before, which was on a weekend, and was going to call the ob on (b)(6).(b)(6) evening, i started bleeding profusely, went to the er, and delivered a (b)(6) who was still born.As of (b)(6) evening she was very active.My ob told me that the essure was dislodged and was sticking out enough in my abdominal space that it ruptured my placenta, which led to fetal demise.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4906077
• MDR Text Key: 6029906
• Report Number: MW5043953
• 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: 06/09/2015

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: 07/10/2015
• Patient Sequence Number: 1
• Treatment: OXYCODONE, TOPAMAX, FLEXERIL, WELLBUTRIN, PROTONIX
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 32.000 YR