GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM

Report

• Report Number: MW5099760
• Event Type: Death
• Date Received: March 3, 2021
• Date of Event: November 5, 2020
• Report Date: February 19, 2021
• Manufacturer: HOLOGIC, INC.
• Product Code: OTE
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
305070	GE, SIEMENS AND HOLOGIC MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM	DIGITAL BREAST TOMOSYNTHESIS	OTE	HOLOGIC, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 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