COR-KNOT MINI DEVICE REF 031350

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-07 for COR-KNOT MINI DEVICE REF 031350 manufactured by Lsi Solutions, Inc..

MAUDE Entry Details

Report NumberMW5090956
MDR Report Key9295357
Date Received2019-11-07
Date of Report2019-11-06
Date of Event2019-10-24
Date Added to Maude2019-11-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 Report0

Device Details

Brand NameCOR-KNOT MINI DEVICE
Generic NameINSTRUMENT, LIGATURE, PASSING AND KNOT TYING
Product CodeHCF
Date Received2019-11-07
Returned To Mfg2019-10-24
Catalog NumberREF 031350
Lot Number754058
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerLSI SOLUTIONS, INC.
Manufacturer AddressVICTOR NY 14564 US 14564


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-07

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