DR COMFORT
Received Dec 29, 2025 · Event occurred Dec 10, 2025
Report 3008579854-2025-00009 · MDR key 23917903
Device
Generic name
Boss Chestnut 11 Wide
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
9520-W-11.0
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED PATIENT WENT TO THE OFFICE WITH A NASTY BLISTER AFTER WEARING THE BOOTS FOR SEVERAL DAYS. UPON INSPECTION OF THE BOOT'S INNER HEEL AREA, THE MATERIAL IS NOT SMOOTH AND FEELS RIGID IN A WAY THAT WILL CAUSE SKIN BREAKDOWN.TREATMENT WAS PROVIDED HERE. THE PROVIDER IS A PODIATRIST. THE SHOE WAS RETURNED AND EVALUATED. EVALUATION OF SHOE FOUND THE HEEL COUNTER IS BENT IN, COMPLAINT HAS BEEN CONFIRMED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Description of Event or Problem
IT WAS REPORTED PATIENT WENT TO THE OFFICE WITH A NASTY BLISTER AFTER WEARING THE BOOTS FOR SEVERAL DAYS. UPON INSPECTION OF THE BOOT'S INNER HEEL AREA, THE MATERIAL IS NOT SMOOTH AND FEELS RIGID IN A WAY THAT WILL CAUSE SKIN BREAKDOWN.TREATMENT WAS PROVIDED HERE. THE PROVIDER IS A PODIATRIST.