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 |