InjuryOAS
I-CAT FLX V17
Received Sep 12, 2024 · Event occurred Aug 13, 2024
Report 3021551875-2024-00003 · MDR key 20201003
Device
Generic name
X-ray, Tomography, Computed, Dental
Manufacturer
Dental Imaging Technologies CorporationModel number
V17Catalog number
0.830.6000
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Male
- Head Injury
- Head Injury
Narrative
Description of Event or Problem
IT WAS REPORTED A PATIENT HIT THEIR HEAD ON A PLASTIC SET SCREW ON THE HORIZONTAL LASER LIGHT WHILE EXITING THE UNIT AFTER THE SCAN HAD BEEN TAKEN. AS A RESULT OF THE INJURY IT WAS REPORTED THE PATIENT REQUIRED STICHES.
Additional Manufacturer Narrative
AN INVESTIGATION OF THE REPORTED INCIDENT IS ONGOING AND NOT YET COMPLETED. ONCE COMPLETE, RESULTS OF THE INVESTIGATION WILL BE SUBMITTED.