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

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

Patient Problem Death (1802)

Event Date 11/05/2020

Event Type  Death  

Event Description

Ge, siemens and hologic unrelated.Breast cancer, nos - unrelated; street drugs - probable.Patient had routine screening mammogram on (b)(6) 2020 without incident, and she was asymptomatic at the time of mammogram.When contact was attempted to have her return for additional views, she was unreachable, and subsequently it was noted in her chart that she had been found dead in her home, of unknown cause, on (b)(6) 2020.She had a history of drug abuse and was suspected to have had an overdose.

• Brand Name: GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM
• Type of Device: DIGITAL BREAST TOMOSYNTHESIS
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 11411722
• MDR Text Key: 234929564
• Report Number: MW5099760
• 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: 02/19/2021

1 Device was Involved in the Event

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: 58 YR
• Patient Weight: 60