FLUENT FLUID MANAGEMENT SYSTEM FLT-112

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 2019-05-20 for FLUENT FLUID MANAGEMENT SYSTEM FLT-112 manufactured by Hologic, Inc..

Event Text Entries

[145634972] 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. 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. Internal complaint reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[145634973] It was reported that at the end of a tissue removal procedure the tissue trap was being collected and tissue was noted on the outside of the trap and at the bottom of the collection container. No injury or misdiagnosis reported. All the tissue was able to be collected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2019-00125
MDR Report Key8624516
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-20
Date of Report2019-04-29
Date of Event2019-04-29
Date Mfgr Received2019-04-29
Date Added to Maude2019-05-20
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 ContactKRISTIN FORNIERI
Manufacturer Street36 & 37 APPLE RIDGE ROAD
Manufacturer CityDANBURY CT 06810
Manufacturer CountryUS
Manufacturer Postal06810
Manufacturer Phone2037318491
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLUENT FLUID MANAGEMENT SYSTEM
Generic NameHYSTEROSCOPIC INSUFFLATOR
Product CodeHIG
Date Received2019-05-20
Model NumberFLT-112
Catalog NumberFLT-112
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC.
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-20

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