MAUDE Adverse Event Report: HOLOGIC INC. MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM; DIGITAL BREAST TOMOSYNTHESIS

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

Patient Problem Death (1802)

Event Date 09/24/2019

Event Type  Death  

Event Description

Gr.5 neoplasms benign, malignant and unspecified "(incl cysts and pol;" subject completed visit 2 (1 year) - dbt (second imaging procedure performed at visit) (b)(6) 2018.Note from ed visit on (b)(6) 2019 states - (b)(6) year old female with a history of liver transplant in 2009 and a recent diagnosis of liver cancer.Subject date of death (b)(6) 2019.Subject was receiving chemotherapy and entered hospice on (b)(6) 2019.Comparison of abbreviated breast mri and digital breast tomosynthesis in breast cancer screening in women with dense breasts.Https://ctepcore.Nci.Nih.Gov/ctepaers/public/reportsecurity?aet id=(b)(6).

• Brand Name: MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM
• Type of Device: DIGITAL BREAST TOMOSYNTHESIS
• Manufacturer (Section D): HOLOGIC INC.
• MDR Report Key: 11411772
• MDR Text Key: 238304262
• Report Number: MW5099761
• 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: Physician
• Type of Report: Initial
• Report Date: 02/25/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 63 YR
• Patient Weight: 70