AIRCAST
Received May 13, 2025 · Event occurred Apr 16, 2025
Report 9616086-2025-00050 · MDR key 22015250
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 · Female
- Abrasion
- Unspecified Infection
- Tissue Breakdown
- Abrasion
- Unspecified Infection
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT RECEIVED THIS BOOT ON (B)(6) 2025 AND THE FRONTAL SUPPORT ON THE BOOT BENT IN A WAY THAT REOPENED THE SURGICAL INCISION, CAUSING PAIN, IMPEDING ITS RECOVERY AND GETTING IT INFECTED AFTER 22 DAYS OF USE. 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 RECEIVED THIS BOOT ON (B)(6) 2025 AND THE FRONTAL SUPPORT ON THE BOOT BENT IN A WAY THAT REOPENED THE SURGICAL INCISION, CAUSING PAIN, IMPEDING ITS RECOVERY AND GETTING IT INFECTED AFTER 22 DAYS OF USE.