AFFIRM PRONE BIOPSY SYSTEM, 3D PBX-SYS-AFFIRM-3D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-23 for AFFIRM PRONE BIOPSY SYSTEM, 3D PBX-SYS-AFFIRM-3D manufactured by Hologic, Inc.

MAUDE Entry Details

Report Number1220984-2019-00101
MDR Report Key9105643
Report SourceUSER FACILITY
Date Received2019-09-23
Date of Report2019-09-03
Date of Event2019-09-03
Date Mfgr Received2019-09-03
Device Manufacturer Date2018-08-17
Date Added to Maude2019-09-23
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 ContactKRISTIN FORNIERI
Manufacturer Street36 & 37 APPLE RIDGE ROAD
Manufacturer CityDANBURY CT 06810
Manufacturer CountryUS
Manufacturer Postal06810
Manufacturer Phone2037318491
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFFIRM PRONE BIOPSY SYSTEM, 3D
Generic NameBREAST BIOPSY SYSTEM
Product CodeIZH
Date Received2019-09-23
Model NumberPBX-SYS-AFFIRM-3D
Catalog NumberPBX-SYS-AFFIRM-3D
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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