InjuryKNP
AIRCAST
Received Mar 5, 2025 · Event occurred Feb 6, 2025
Report 9616086-2025-00014 · MDR key 21532031
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Abrasion
- Tissue Breakdown
- Abrasion
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT WAS ISSUED AN AIRSELECT ELITE MEDIUM BOOT (O1EP-M). PATIENT WAS SEEN TODAY FOR A PRESSURE ULCER RESULTING FROM WEARING THE BOOT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF MORE INFORMATION BECOMES AVAILABLE ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS ISSUED AN AIRSELECT ELITE MEDIUM BOOT (O1EP-M). PATIENT WAS SEEN TODAY FOR A PRESSURE ULCER RESULTING FROM WEARING THE BOOT.