MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Loose or Intermittent Connection (1371); Unexpected Therapeutic Results (1631)

Patient Problems Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Urinary Tract Infection (2120); Neck Pain (2433); Weight Changes (2607); No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2015

Event Type  Injury  

Event Description

(b)(4).Well started the month after getting the essure place started having pains during intercourse urinary tract infections all the time ,pelvic pain, memory loss, severe neck and head pain.Migraines to the point that made me sick and no meds would work to stop the headache, weight gain, metal taste in the mouth, hair loss , and teeth problems.

Event Description

(b)(4).I will be having the essure removed (b)(6) due to pain during intercourse severe headaches pelvic pain missed periods etc.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5019151
• MDR Text Key: 23629348
• Report Number: MW5055625
• 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: Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 23.000 YR