FDA Adverse Event
Injury
Summary report: N
RADIATION SHIELD SYSTEM
MDR report key: 17527387
·
Received August 12, 2023
Report
- Report Number
- MW5134319
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- June 4, 2021
- Manufacturer
- KENEX
- Product Code
- KPY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS IS TO INFORM YOU THAT A GE HEALTHCARE FIELD SERVICE ENGINEER HAS BEEN INJURED DURING A SERVICE ACTIVITY ON A 2100-IQ GE SYSTEM. DURING THE REPAIR OF THE VASCULAR TABLE, THE GEHC FIELD SERVICE ENGINEER STOOD UP SUDDENLY AND BUMPED HIS HEAD ON THE RADIATION SHIELD MANUFACTURED BY KEN EX. HE WAS TREATED AT THE HOSPITAL WHERE HE WAS AND HAD 2 STITCHES. IT WAS CONFIRMED THAT THERE WAS NO GE HEALTHCARE SYSTEM INVOLVED THAT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597428 | RADIATION SHIELD SYSTEM | SHIELD, PROTECTIVE, PERSONNEL | KPY | KENEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |