NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-04 for NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UNKNOWN manufactured by Hologic, Inc.

Event Text Entries

[178017838] Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device is not being returned therefore, a failure analysis of the complaint device cannot be completed. If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10


[178017839] This is the second of two hologic reports related to this event. Please also refer to 1222780-2020-00021 for the first report. It was reported to hologic by the performing physician that in october or (b)(6) of 2019, he had completed an uncomplicated fibroid removal procedure followed by an endometrial ablation. Both procedures were completed without incident. The physician stated "the patient went home with some discomfort however later on in the evening the patient was not feeling well. " he suggested the patient go to the emergency department. The patient arrived that night at 1:00am and had blood work done with culture. The culture results were positive for strep and sepsis. The patient was monitored and prescribed medication. The patient had a laparoscopic procedure three days later to rule out any puss or infection in the abdomen. "there were no findings of infection in the abdomen and all looked benign. " a hysteroscopy was also performed and there was no signs of any puss or fluid build up in the uterine cavity. The physician stated the patient is doing very well and no signs of infection to report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00022
MDR Report Key9663284
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-04
Date of Report2020-01-16
Date Mfgr Received2020-01-16
Date Added to Maude2020-02-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKELSEA LYVER
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082636130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOVASURE IMPEDANCE CONTROLLED EA SYSTEM
Generic NameUTERINE ABLATION DEVICE
Product CodeMNB
Date Received2020-02-04
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2020-02-04

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