FDA Adverse Event
Injury
Summary report: N
VERITON CT 364
MDR report key: 23447341
·
Received November 3, 2025
Report
- Report Number
- MW5178449
- Event Type
- Injury
- Date Received
- November 3, 2025
- Date of Event
- October 22, 2025
- Report Date
- October 30, 2025
- Manufacturer
- SPECTRUM DYNAMICS MEDICAL LTD.
- Product Code
- KPS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ON (B)(6) 2025, AN EMAIL NOTIFICATION WAS RECEIVED FROM THE COMPANY`S CLINICAL SPECIALIST REGARDING A POTENTIAL SAFETY ISSUE WITH THE PATIENT. AS PER THE NOTIFICATION, THE PATIENT CAME TO THE NUCLEAR IMAGING DEPARTMENT TO HAVE BONE SCINTIGRAPHY SCHEDULED FOR THE VERITON CT SYSTEM. WHILE THE PATIENT'S SUPPORT STRETCHER MOVED TOWARDS THE NM BORE, THEIR FINGER (NUMBER 4, RIGHT WRIST) WAS TRAPPED BETWEEN THE STRETCHER AND THE CATCHER ROLLER. THERE HAS BEEN NO SIGNIFICANT DETERIORATION IN THE PATIENT'S HEALTH DUE TO THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224898 | VERITON CT 364 | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION | KPS | SPECTRUM DYNAMICS MEDICAL LTD. | 364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Other |