FDA Adverse Event
Death
Summary report: N
UTERINE ARTERY EMBOLIZATION
MDR report key: 1661527
·
Received April 13, 2010
Report
- Report Number
- MW5015536
- Event Type
- Death
- Date Received
- April 13, 2010
- Date of Event
- November 19, 2009
- Report Date
- April 13, 2010
- Product Code
- NAJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
REPORTED BY A FAMILY MEMBER. WOMAN DIED 13 DAYS POST UAE. SHE WAS HOSPITALIZED OVERNIGHT, DISCHARGED NEXT DAY, READMITTED TO THE HOSPITAL WITH NO PULSE AND MASSIVE BLOOD CLOTS IN HER LEG. SHE APPARENTLY UNDERWENT UNWARRANTED HEART SURGERY AND EXPIRED 13 DAYS POST UAE. DATES OF USE: PERMANENT. DIAGNOSIS OR REASON FOR USE: FIBROIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UTERINE ARTERY EMBOLIZATION | NAJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death| H| O |