InjuryIKZ
ROTOPRONE
Received Apr 15, 2026 · Event occurred Mar 16, 2026
Report 9681684-2026-00035 · MDR key 24880720
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Patient Device Interaction Problem
Patient
NA · Unknown
- Pressure Sore/Ulcer
- Skin Tears
Narrative
Additional Manufacturer Narrative
NO UDI INFORMATION IS AVAILABLE, THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION. INVESTIGATION IS ONGOING. ONCE IT WILL BE COMPLETED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.
Description of Event or Problem
CUSTOMER REPORTED THAT THE PATIENT HAD DEVELOPED PRESSURE INJURY ON THE BRIDGE OF THE NOSE AND THE CHEEKS. ACCORDING TO THE CUSTOMER THE INJURIES TO THE CHEEK ARE FROM THE ENDOTRACHEAL TUBE HOLDER.