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