FDA Adverse Event
Injury
Summary report: N
PVA
MDR report key: 1981190
·
Received February 2, 2011
Report
- Report Number
- MW5019276
- Event Type
- Injury
- Date Received
- February 2, 2011
- Date of Event
- April 20, 2007
- Report Date
- February 2, 2011
- 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
MENSTRUATION CEASED POST UAE. THREE YEARS POST UAE FOLLOWING POLYPECTOMY AT CERVICAL OS AND ENDOMETRIAL BIOPSY. FORTY-EIGHT HOURS LATER, DEVELOPED GREEN VAGINAL DISCHARGE AND HIGH FEVER. UNRESPONSIVE TO TREATMENT. SYMPTOMS INCREASED IN SEVERITY INCLUDING SHOOTING ABDOMINAL PAIN, MODERATE TO SEVERE PAIN VOIDING, PAINFUL TO TOUCH AND ONE EPISODE OF VAGINAL BLEEDING. SUBSEQUENTLY DX WITH PELVIC INFLAMMATORY DISEASE. SCANNING REVEALED FIBROID GREW SLIGHTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PVA | UTERINE ARTERY EMBOLIZATION | NAJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |