MAUDE Adverse Event Report: HOLOGIC, INC. GE, SIEMENS AND HOLOGIC; DIGITAL BREAST TOMOSYNTHESIS

Model Number SELENIA DIMENSIONS 8000 TOMO

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/31/2018

Event Type  Death  

Event Description

Patient enrolled on (b)(6) and completed time 1 breast mri (b)(6) 2017.When contacted for scheduling her time 2 breast mri in (b)(6) 2018, patient shared she had been diagnosed with urethral cancer and withdrew from study participation but agreed to follow-up with study team.Study team was notified by patient's spouse that she passed away in (b)(6) 2018 from disease progression after patient discontinued therapy in (b)(6) 2018 but team was unable to get an exact date of death.On (b)(6) 2018 is provided as an approximate date of death for this subject.

• Brand Name: GE, SIEMENS AND HOLOGIC
• Type of Device: DIGITAL BREAST TOMOSYNTHESIS
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 11421152
• MDR Text Key: 238402993
• Report Number: MW5099787
• Device Sequence Number: 1
• Product Code: OTE
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SELENIA DIMENSIONS 8000 TOMO
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 61 YR
• Patient Weight: 56