MAUDE Adverse Event Report: UTERINE FIBROID EMBOLIZATION

UTERINE FIBROID EMBOLIZATION

Device Problem Insufficient Information (3190)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Type Injury

Event Description

She had a uterine fibroid embolization four-five years ago.She has since the ablation, experienced sporadic poor circulation in her legs and feet.

1 Device was Involved in the Event
Brand Name	UTERINE FIBROID EMBOLIZATION
Type of Device	UTERINE FIBROID EMBOLIZATION
MDR Report Key	5113363
MDR Text Key	27216440
Report Number	MW5056604
Device Sequence Number	1
Product Code	NAJ
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Voluntary
Reporter Occupation	Other Health Care Professional
Report Date	09/23/2015
1 Patient was Involved in the Event
Date FDA Received	09/23/2015
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
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Other;