MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Depression (2361); Abdominal Cramps (2543); Heavier Menses (2666)

Event Date 04/11/2012

Event Type  Injury  

Event Description

Moodiness, depression, suicidal thoughts, bloating, allergies, headaches, fatigue, chronic abdominal cramping, heavy periods, irregular periods, pain on right side of abdomen, migration of essure coil, essure coil protruding through right fallopian tube, rash, itching, hysterectomy on (b)(6) 2014, fragment surgery on (b)(6) 2014.(b)(4).

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 3884414
• MDR Text Key: 4592187
• Report Number: MW5036670
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: NAPROXIN, TYLENOL, IBUPROFIN
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 39.000 YR