MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM

Report

• Report Number: MW5099761
• Event Type: Death
• Date Received: March 3, 2021
• Date of Event: September 24, 2019
• Report Date: February 25, 2021
• Manufacturer: HOLOGIC INC.
• Product Code: OTE
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 1

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).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
305084	MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM	DIGITAL BREAST TOMOSYNTHESIS	OTE	HOLOGIC INC.	UNK
305085	MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM	DIGITAL BREAST TOMOSYNTHESIS	OTE	GE MEDICAL SYSTEMS SCS
305086	MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM	DIGITAL BREAST TOMOSYNTHESIS	OTE	SIEMENS AG/SIEMENS HEALTHCARE GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Death| H

Terms

Patient problem · 1

• Death

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission