IRIS D-EDGE SCISSORS CVD 4-1/2(11.5CM) 32-0705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for IRIS D-EDGE SCISSORS CVD 4-1/2(11.5CM) 32-0705 manufactured by Carefusion, Inc.

MAUDE Entry Details

Report Number1423507-2019-00009
MDR Report Key8600305
Date Received2019-05-10
Date of Report2019-07-22
Date of Event2019-04-01
Date Mfgr Received2019-04-29
Device Manufacturer Date2016-02-01
Date Added to Maude2019-05-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactBDX ANNA WEHRHEIM
Manufacturer Street75 NORTH FAIRWAY DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer G1CAREFUSION, INC
Manufacturer Street75 NORTH FAIRWAY DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal Code60061
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIRIS D-EDGE SCISSORS CVD 4-1/2(11.5CM)
Generic NameINSTRUMENTS, SURGICAL, CARDIOVASCULAR
Product CodeLRW
Date Received2019-05-10
Catalog Number32-0705
Lot NumberXTAZ02
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-10

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