FDA Adverse Event
Injury
Summary report: N
VERITON CT
MDR report key: 23369485
·
Received October 23, 2025
Report
- Report Number
- MW5177896
- Event Type
- Injury
- Date Received
- October 23, 2025
- Date of Event
- August 19, 2025
- Report Date
- October 19, 2025
- Manufacturer
- SPECTRUM DYNAMICS MEDICAL LTD.
- Product Code
- KPS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE PATIENT HAD COME TO THE NUCLEAR IMAGING DEPARTMENT FOR A BONE SCINTIGRAPHY STUDY USING THE VERITON CT SYSTEM. DURING THE MOVEMENT OF THE PATIENT SUPPORT STRETCHER INTO THE CT BORE, THE PATIENT'S LEFT THUMB WAS PINCHED BETWEEN THE STRETCHER AND THE CATCHER'S ROLLER. THE PATIENT REQUIRED FIVE STITCHES FOR THE INJURY, BUT THERE WAS NO SERIOUS DETERIORATION IN THE PATIENT'S OVERALL HEALTH. PATIENT WITH PARESTHESIA IN THE LEFT ARM SCHEDULED FOR BONE SCINTIGRAPHY. POSITIONED FEET-FIRST ON THE TABLE; ARM BELT PLACED AT ELBOWS AND ADJUSTED. PATIENT'S LEFT THUMB PINCHED AS STRETCHER EXTENDED DURING LOCALIZER SCAN. NO TRACES OF BLOOD FOUND ON MOVING PARTS. FSE RECREATED EVENT; PATIENT'S WRIST MAY HAVE TILTED DOWNWARD DESPITE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1611886 | VERITON CT | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION | KPS | SPECTRUM DYNAMICS MEDICAL LTD. | 316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |