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

Model Number SDA-SYS-3000-3D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported that customer was injured while installing the mag stand on system.The mag stand was not latched all the way and fell while the customer still had a hold of it, resulting in injury of both index fingers.No system service was required as this was user error not a malfunction.The machine is currently operating to hologic's specification.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Type of Device: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: evelyn lopez ; 36 & 37 apple ridge road; danbury, CT 06810
• MDR Report Key: 14698490
• MDR Text Key: 294925640
• Report Number: 1220984-2022-00054
• Device Sequence Number: 1
• Product Code: OTE
• UDI-Device Identifier: 15420045505636
• UDI-Public: (01)15420045505636(11)170915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDA-SYS-3000-3D
• Device Catalogue Number: SDA-SYS-3000-3D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other