SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM SDM-00001-2D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-16 for SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM SDM-00001-2D manufactured by Hologic, Inc.

Event Text Entries

[183723208] It was reported that when using the footswitch to move the x-ray arm down the "x-ray arm dropped down suddenly. " no injury reported. A field engineer was dispatched to the site and determined the footswitch needed to be replaced. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220984-2020-00039
MDR Report Key9835711
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-16
Date of Report2020-02-21
Date of Event2020-02-21
Date Mfgr Received2020-02-21
Device Manufacturer Date2013-01-01
Date Added to Maude2020-03-16
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
Manufacturer CountryUS
Manufacturer Phone7318491
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
Generic NameFULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Product CodeMUE
Date Received2020-03-16
Model NumberSDM-00001-2D
Catalog NumberSDM-00001-2D
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address36 & 37 APPLE RIDGE ROAD DANBURY, CT US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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