X-REIDY BREAST LESION LOCALIZATION NEEDLE N/A DXRBL-19.5-9.0-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-25 for X-REIDY BREAST LESION LOCALIZATION NEEDLE N/A DXRBL-19.5-9.0-S manufactured by Cook Inc.

MAUDE Entry Details

Report Number1820334-2019-02950
MDR Report Key9371591
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-25
Date of Report2019-11-25
Date of Event2019-11-13
Date Mfgr Received2019-11-13
Device Manufacturer Date2019-04-15
Date Added to Maude2019-11-25
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 ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameX-REIDY BREAST LESION LOCALIZATION NEEDLE
Generic NameMIJ NEEDLE, TUMOR LOCALIZATION
Product CodeMIJ
Date Received2019-11-25
Model NumberN/A
Catalog NumberDXRBL-19.5-9.0-S
Lot Number9668779
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-25

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