PVA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-05 for PVA manufactured by .

Event Text Entries

[5700556] She was a physicians assistant. Had uae for 6 month size fibroid. Two months post uae started passing necrotic debris and anaerobic vaginal discharge. She was admitted to (b)(6) hosp and a drain was placed thru the cervical os for eleven days. When drain was removed she became septic. On (b)(6) 98, two weeks after drain was removed, she underwent total abdominal hysterectomy. She had persistent perineum burning, bladder was found to have scar tissue resulting from possible perforation during hysterectomy. Multiple necrotic tissue with bacterial growth was found. She was discharged with uti, enterococcus. She continues to have persistent perineum burning and ic seen on cystoscopy under general anesthesia. She continues neuropathic, but that she has a small fistula vesicovaginal cuff. No doctor has seen it. She has been unable to have intercourse due to the burning. An interstim was placed s4 with some decrease in pain. Continues to have burning 24/7 and always in the same area.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5041370
• MDR Report Key: 4603092
• Date Received: 2015-03-05
• Date of Report: 2015-03-05
• Date of Event: 1998-08-01
• Date Added to Maude: 2015-03-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PVA
• Generic Name: UTERINE ARTERY EMBOLIZATION
• Product Code: NAJ
• Date Received: 2015-03-05
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2015-03-05