MAUDE Adverse Event Report:; UTERINE ARTERY EMOBLIZATION

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Fever (1858); Pain (1994); Chills (2191); Discharge (2225)

Event Date 08/26/2006

Event Type  Injury  

Event Description

One month after (b)(6) patient felt extreme pelvic pain, worst pain ever experienced.Required high dose morphine and heating pads to reduce pain.High fevers, chills the first five days.Contracted a bacterial infection for 2-4 weeks after uae.She had a thick, foul smelling discharge followed by the passing of necrotic fibroid.Immediate relief of pain followed.Eight months post uae she stopped having pain, discharge and menstrual periods.Since then she has had no sex drive, extreme vaginal dryness and painful sexual intercourse.She has very low estrogen levels and menopausal symptoms.

• Brand Name: NI
• Type of Device: UTERINE ARTERY EMOBLIZATION
• MDR Report Key: 4603110
• MDR Text Key: 17945147
• Report Number: MW5041371
• Device Sequence Number: 1
• Product Code: NAJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability