HYDROMARK BREAST BIOPSY SITE MARKER 4010-02-15-T4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-15 for HYDROMARK BREAST BIOPSY SITE MARKER 4010-02-15-T4 manufactured by Devicor Medical Products, Inc..

MAUDE Entry Details

Report Number3008492462-2019-00040
MDR Report Key8897042
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-08-15
Date of Report2019-08-15
Date of Event2019-07-18
Date Mfgr Received2019-07-18
Device Manufacturer Date2018-04-11
Date Added to Maude2019-08-15
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. JILL BURNETT
Manufacturer Street300 E. BUSINESS WAY FIFTH FLOOR
Manufacturer CityCINCINNATI OH 45241
Manufacturer CountryUS
Manufacturer Postal45241
Manufacturer G1DEVICOR MEDICAL PRODUCTS, INC.
Manufacturer Street300 E. BUSINESS WAY FIFTH FLOOR
Manufacturer CityCINCINNATI OH 45241
Manufacturer CountryUS
Manufacturer Postal Code45241
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Generic NameBIOPSY SITE MARKER
Product CodeNEU
Date Received2019-08-15
Model Number4010-02-15-T4
Catalog Number4010-02-15-T4
Lot Number200044907
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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. Required No Informationntervention 2019-08-15

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