TK? TI-KNOT? DEVICE 030404

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for TK? TI-KNOT? DEVICE 030404 manufactured by Lsi Solutions, Inc..

MAUDE Entry Details

Report Number8955423
MDR Report Key8955423
Date Received2019-09-03
Date of Report2019-07-31
Date of Event2019-02-05
Report Date2019-07-31
Date Reported to FDA2019-07-31
Date Reported to Mfgr2019-09-03
Date Added to Maude2019-09-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTK? TI-KNOT? DEVICE
Generic NameINSTRUMENT, LIGATURE PASSING AND KNOT TYING
Product CodeHCF
Date Received2019-09-03
Model Number030404
Catalog Number030404
Lot Number736843
Device AvailabilityY
Device Age0 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLSI SOLUTIONS, INC.
Manufacturer Address7796 VICTOR-MENDON ROAD VICTOR NY 14564 US 14564


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-03

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