ECONOMY SOFT TISSUE BIOPSY TRAY 4380

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for ECONOMY SOFT TISSUE BIOPSY TRAY 4380 manufactured by Carefusion, Inc.

MAUDE Entry Details

Report Number1625685-2019-00063
MDR Report Key8754423
Date Received2019-07-02
Date of Report2019-08-05
Date of Event2019-05-29
Date Mfgr Received2019-08-05
Date Added to Maude2019-07-02
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 N. FAIRVIEW DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer G1CAREFUSION, INC
Manufacturer Street400 EAST FOSTER RD
Manufacturer CityMANNFORD OK 74044
Manufacturer CountryUS
Manufacturer Postal Code74044
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameECONOMY SOFT TISSUE BIOPSY TRAY
Generic NameTRAY, SURGICAL, NEEDLE
Product CodeFSH
Date Received2019-07-02
Catalog Number4380
Lot Number0001257428
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address400 EAST FOSTER RD MANNFORD OK 74044 US 74044


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-02

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