NOVASURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for NOVASURE manufactured by Hologic, Inc..

Event Text Entries

[183118317] Overall i am a healthy married mom of 2 and after my last child i had a tubal sterilization in 2007. There after i continued having terrible menstrual cycles and bleeding. So my gynecologist suggested i have ablation of the uterus. In (b)(6) of 2016 i had the procedure done and for 3 months no menstrual related pain or bleeding. Months after my novasure i began to have multiple unexplained gastric and bowel issues as well bladder pain and neurological dizziness. The right internal organs are causing pressure on nerves and lymph nodes. Within the past 3 years i have done multiple imaging mri, angiogram, ct scan and saw a variety of health professional from neurologist, urologist, rheumatoid orthopedics, sleep specialists, pcp of which found no answers to my issues. However the pain in my right pelvic area and leg regional has been so severe that it has caused me to have unnecessary surgery in (b)(6) of 2019 of right ankle to remove a nerve that initially appeared on an eeg positive for sciatic neuropathy and tarsal tunnel syndrome was thought to cause the right pelvic / leg pain, but it was not it, was the failed novasure procedure. In all, the novasure has required me to get hysterectomy in a couple of months along with removal of right fallopian tube. I am diagnosed with post-ablation tubal sterilization syndrome caused by my gynecologist who did not consider the warnings that novasure had presented. I would only suggest that the mfr of novasure have sticker restrictions on novasure candidates as well as the providers performing procedures. Had i been told that i was not a candidate (previous tubal sterilization), i would have never ever had the procedure and opted for a hysterectomy. If there anyway the fda to hold health professional accountable for disregarding a medical device warning that would be greatly appreciated from thousands of women who have been severely damaged and eliminate unnecessary visit to unrelated providers due to their symptoms. Hypoechoic focus of the uterus with severe hemorrhagic debris of endometrium, complex cyst of ovaries, fluids. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093638
• MDR Report Key: 9810916
• Date Received: 2020-03-09
• Date of Report: 2020-03-06
• Date of Event: 2017-01-07
• Date Added to Maude: 2020-03-10
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NOVASURE
• Generic Name: DEVICE, THERMAL ABLATION ENDOMETRIAL
• Product Code: MNB
• Date Received: 2020-03-09
• Device Expiration Date: 2016-09-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOLOGIC, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2020-03-09