MalfunctionEFD
VIALMIX®RFID DEFINITY
Received Jul 17, 2025 · Event occurred Jun 26, 2025
Report 22529697 · MDR key 22529697
Device
Generic name
Amalgamator, Dental, Ac-powered
Manufacturer
Lantheus Medical Imaging, Inc.Model number
VMIX2Catalog number
VMIX2
Lot number
1366
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Chest Pain
- Back pain
- Chest Pain
- Back pain
Narrative
Description of Event or Problem
TWO DEFINITY REACTIONS: 1. [DATE REDACTED] ---LOT # 1366 ---IMMEDIATELY AFTER ECHO [ECHOCARDIOGRAM] WAS COMPLETED, PATIENT HAD EXCRUCIATING BACK PAIN AND CHEST PAIN. PAIN RESOLVED AFTER A FEW MINUTES. 2. [DATE REDACTED] ----LOT# 6372 ---APPROX 10-15 MINUTES AFTER ECHO COMPLETED, PATIENT HAD 10/10 PAIN IN HIS UPPER HIP AREA.