MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

Model Number	SDM-SYS-6000-3D
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in-process, a follow-up will be filed as needed.
Event or Problem Description
It was reported that when taking a sample with a needle it hit the breast platform.No injury reported.A field engineer was dispatched to the site.Additional information has been requested.
Additional Manufacturer Narrative
If additional information is received regarding this event a follow up will be filed as needed.
Event or Problem Description
Attempts to obtain additional information have been unsuccessful.

• 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 Key: 8601143
• Report Number: 1220984-2019-00051
• Device Sequence Number: 13955984
• Product Code: OTE
• UDI-Device Identifier: 15420045505636
• UDI-Public: 15420045505636
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P080003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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 Number: SDM-SYS-6000-3D
• Device Catalogue Number: SDM-SYS-6000-3D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1