FLUENT FLUID MANAGEMENT SYSTEM FLT-112S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-05 for FLUENT FLUID MANAGEMENT SYSTEM FLT-112S manufactured by Hologic, Inc.

MAUDE Entry Details

Report Number1222780-2019-00179
MDR Report Key8862422
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-08-05
Date of Report2019-07-18
Date of Event2019-07-18
Date Mfgr Received2019-07-18
Device Manufacturer Date2018-11-21
Date Added to Maude2019-08-05
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 NameFLUENT FLUID MANAGEMENT SYSTEM
Generic NameHYSTEROSCOPIC INSUFFLATOR
Product CodeHIG
Date Received2019-08-05
Model NumberFLT-112S
Catalog NumberFLT-112S
Lot Number18L21RB
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
10 2019-08-05

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