AFFIRM BREAST BIOPSY GUIDANCE SYSTEM STLC-00004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-29 for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM STLC-00004 manufactured by Hologic, Inc.

Event Text Entries

[143423526] As of today the investigation is still in process and a follow up will be filed as needed.
Patient Sequence No: 1, Text Type: N, H10


[143423527] It was reported that "the bcm monitor is flickering and will change views and sometimes the targets. " no injury reported. A field engineer was dispatched to the site.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220984-2019-00042
MDR Report Key8560945
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-04-29
Date of Report2019-04-03
Date of Event2019-04-03
Date Mfgr Received2019-05-10
Device Manufacturer Date2015-06-01
Date Added to Maude2019-04-29
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 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 BREAST BIOPSY GUIDANCE SYSTEM
Generic NameBIOPSY GUIDANCE SYSTEM
Product CodeIZH
Date Received2019-04-29
Model NumberSTLC-00004
Catalog NumberSTLC-00004
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-29

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