FDA Adverse Event Injury Summary report: N

GUERBET ANGIOMAT ILLUMENA INJECTOR

MDR report key: 15044075 · Received July 15, 2022

Report

Report Number
MW5110930
Event Type
Injury
Date Received
July 15, 2022
Date of Event
July 6, 2022
Report Date
July 14, 2022
Manufacturer
GUERBET / LIEBEL-FLARSHEIM COMPANY LLC
Product Code
DXT
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KY, US
Reporter Occupation
BIOMEDICAL ENGINEER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

GUERBET ANGIOMAT ILLUMENA INJECTOR SYRINGES EXPLODING DURING CONTRAST INJECTION. (PART# 236303). FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
240355 GUERBET ANGIOMAT ILLUMENA INJECTOR INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT GUERBET / LIEBEL-FLARSHEIM COMPANY LLC ANGIOMAT ILLUMENA SYRINGE 20210106

Patients

Seq Age Sex Outcome Treatment
1 Unknown Required Intervention