HYDROMARK BREAST BIOPSY SITE MARKER 4010-01-11-T3

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 2019-11-02 for HYDROMARK BREAST BIOPSY SITE MARKER 4010-01-11-T3 manufactured by Devicor Medical Products Inc.

MAUDE Entry Details

Report Number3008492462-2019-00049
MDR Report Key9269831
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-02
Date of Report2019-11-01
Date of Event2018-07-01
Date Mfgr Received2019-08-26
Date Added to Maude2019-11-02
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 ContactMRS. RHONDA KOPS
Manufacturer Street300 E BUSINESS WAY FIFTH FLOOR
Manufacturer CityCINCINNATI OH 45241
Manufacturer CountryUS
Manufacturer Postal45241
Manufacturer G1DEVICOR MEDICAL PRODUCTS DE MEXICO
Manufacturer StreetSOR JUANAINES DE LA CRUZ #20152 4-B
Manufacturer CityPARQUE INDUSTRIAL, 22440
Manufacturer CountryMX
Manufacturer Postal Code22440
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Generic NameBREAST BIOPSY SITE MARKER
Product CodeNEU
Date Received2019-11-02
Model Number4010-01-11-T3
Catalog Number4010-01-11-T3
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEVICOR MEDICAL PRODUCTS INC
Manufacturer Address300 E BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-02

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