NOVASURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for NOVASURE manufactured by Hologic, Inc.

Event Text Entries

[183546145] Novasure ablation in 2013 due to extremely cyclic pain and heavy bleeding. Previous tubal litigation in 2007, which should have excluded me from having the ablation. Bleeding stopped (spotting only) with ablation and all was good until 2015, again i was hit with painful cyclic pain and heavier spotting. This would occur every few months. On (b)(6) 2018 had cyclic pain and more bleeding, then nothing until (b)(6) 2019, when i had heavier spotting and extreme pain. On (b)(6) 2019 i awakened to bleeding and extreme pain in my pelvic area more on the left side. Pain continues to get worse until i have no other alternative than to go to the emergency room due to extreme labor like pains that affected my lower back, pelvic area more on the left side and my left hip and leg area. Was given morphine which only dulled the pain. Was released and pain continued for 3 days and brownish spotting for moe than a week. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093703
• MDR Report Key: 9824445
• Date Received: 2020-03-11
• Date of Report: 2020-03-09
• Date of Event: 2019-12-16
• Date Added to Maude: 2020-03-12
• 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: 2020-03-11
• Device Availability: *
• 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		2020-03-11