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

Model Number	RM-SDM-00001-3D
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that as the technologist and patient were entering the exam room, the operator shield shattered.No patient impact.The technologist received two superficial cuts on her hand which did not require any medical intervention.A field engineer was dispatched to the site and the operator shield was replaced.

• 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: 7797444
• Report Number: 1220984-2018-00136
• Device Sequence Number: 182061
• Product Code: OTE
• UDI-Device Identifier: 15420045505582
• UDI-Public: 15420045505582
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P080003
• Number of Events Summarized: 1
• 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): 07/23/2018

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 Number: RM-SDM-00001-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1