MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FILED DIGITAL MAMMOGRAPHY SYSTEM

Model Number	SDM-00001-2D
Medical Device Problem Codes	Human-Device Interface Problem (2949); Physical Property Issue (3008)
Health Effect - Clinical Codes	Fall (1848); Fracture, Arm (2351)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018 our field engineer went to the site for an service call for another machine at the site, when he arrived they told him that a technician had fallen and broken her wrist in room 3.He went to check out that machine.He stated the mag stand resides on a small round table, in the corner of the room behind the gantry.The area where the table sits is very tight.In the past, i myself have had trouble retrieving the mag stand to use.He has recommended they not store the mag stand there.He did tie wrap what little access wire there was.
Event or Problem Description
It was reported to our field engineer when he arrived onsite later in the day on (b)(6) 2018, that the morning after the technician had finished the part of qa that used the mag stand, she had gone behind the system, placed the mag stand down.When she went to turn in the small space, they had when she lifted her foot to step over the foot pedal wire it must have looped over her foot and as she moved forward, tightened and she fell.She was taken to the emergency room for x-rays.She received a fracture of the left wrist and a tiny chip off the end of the ulna bone.They put a splint on her wrist and was back to work in a couple of days.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Common Device Name: FULL FILED DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 7267653
• Report Number: 1220984-2018-00086
• Device Sequence Number: 13822016
• Product Code: MUE
• UDI-Device Identifier: 15420045505582
• UDI-Public: 15420045505582
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: PO10025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Radiologic Technologist
• Device Model Number: SDM-00001-2D
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other