Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D Back to Search Results
Model Number SDM-00001-3D
Medical Device Problem Code Unintended System Motion (1430)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 06/18/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a needle localization procedure the technologist was positioning the patient and the c-arm rotated downward and impacted her shoulder.No patient impact.The technologist was evaluated and an x-ray was done with normal results.She had discomfort, but no redness or bruising and no further medical intervention was needed.A field engineer was dispatched to the site and it was determined that the c-arm control switches needed to be replaced.Once this was completed the system is working as intended.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
Common Device Name
MAMMOGRAPHY SYSTEM
Manufacturer (Section D)
HOLOGIC, INC
36 & 37 apple ridge road
danbury CT 06810
MDR Report Key7694321
Report Number1220984-2018-00116
Device Sequence Number1452509
Product Code OTE
UDI-Device Identifier15420045505582
UDI-Public15420045505582
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P080003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberSDM-00001-3D
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2018
Initial Report FDA Received Date07/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-