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,user f report with the FDA on 2020-01-28 for FLUENT FLUID MANAGEMENT SYSTEM FLT-112S manufactured by Hologic, Inc.

Event Text Entries

[178638321] The date of the event was not provided, the incident date remains unknown. Hologic became aware of this event on january 09 2020. Lot and serial 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 was 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


[178638322] It was reported that during a procedure at an unknown date, the tissue trap burst resulting in a lost tissue sample. The device involved was a fluent fluid management system. There is no known impact to patient, no injuries reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2020-00011
MDR Report Key9640053
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-28
Date of Report2020-01-09
Date Mfgr Received2020-01-09
Date Added to Maude2020-01-28
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 Received2020-01-28
Model NumberFLT-112S
Catalog NumberFLT-112S
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
10 2020-01-28

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