MAUDE Adverse Event Report: HOLOGIC, INC. MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number SECUR VIEW DX

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

Patient Problems Dyspnea (1816); Scar Tissue (2060); Viral Infection (2248); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/15/2022

Event Type  Death  

Event Description

Patient seen at urgent care facility on (b)(6) 2022 for suspected upper respiratory viral illness.Chest x-ray read as showing interstitial markings in the area patient had pneumonia in 2 years prior; differential included atypical infection, viral infection, with right lower lobe scarring/atelectasis or developing pneumonia.Patient advised to monitor symptoms and if worsening over the next 2-5 days return to urgent care for repeat chest x-ray and compare with chest x-ray from today.Otc items such as acetaminophen, cough drops, saline nasal rinses suggested.Patient tested negative for covid on (b)(6) 2022 and (b)(6) 2022.On (b)(6) 2022, patient returned to urgent care with continued productive cough and worsened shortness of breath.Repeat chest x-ray showed findings like the chest x-ray 3 days prior.Physician advised patient to stop medrol which had been previously prescribed by her orthopedic surgeon, and begin levaquin, benzonatate and albuterol and return in 2-3 days if not improving.No further documentation on her illness is available.According to patient's obituary, she passed away suddenly on (b)(6) 2022, in the mediterranean.Additional circumstances regarding her death are not available.

• Brand Name: MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 16294073
• MDR Text Key: 308829634
• Report Number: MW5114646
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SECUR VIEW DX
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 66 KG