AIRCAST
Received Mar 7, 2026 · Event occurred Feb 5, 2026
Report 9616086-2026-00005 · MDR key 24540564
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Female
- Ulcer
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT WAS CREATED BECAUSE THE DEVICE WAS RETURNED. RETURNED PRODUCT INSPECTED AND COMPLAINT COULD NOT BE CONFIRMED, THE TECHNICIAN EVALUATION INDICATES INCIDENT IS NOT ATTRIBUTABLE TO A DESIGN, PRODUCT QUALITY, OR LABELING DEFICIENCY OF THE DEVICE. THE ROOT CAUSE CANNOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF MORE IS INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT HAS A BLISTER/ULCER ON HER HEEL. NO FURTHER INFORMATION WAS PROVIDED. 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 HAS A BLISTER/ULCER ON HER HEEL. NO FURTHER INFORMATION WAS PROVIDED.