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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
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HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM Back to Search Results
Model Number SDM-00001-2D
Device Problem Naturally Worn (2988)
Patient Problem Not Applicable (3189)
Event Date 12/11/2017
Event Type  malfunction  
Event Description
It was reported that the technician got a shock when she touched the fingerprint scanner pad.The technician was fine and received no medical treatment.It was determined that the powder coat around the scanner was worn off.The entire powder coat is being replaced, as there are other areas where it is worn.
 
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Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
Type of Device
FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC.
36 & 37 apple ridge road
danbury CT 06810
Manufacturer Contact
debra rosenberg
36 & 37 apple ridge road
danbury, CT 06810
2032074512
MDR Report Key7176983
MDR Text Key96939714
Report Number1220984-2018-00038
Device Sequence Number1
Product Code MUE
UDI-Device Identifier15420045505582
UDI-Public15420045505582
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PO10025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberSDM-00001-2D
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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