DR COMFORT
Received Aug 25, 2025 · Event occurred Jul 25, 2025
Report 3008579854-2025-00001 · MDR key 22891748
Device
Generic name
Spirit X White Velcro 7 Xwide
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
2440R-X-07.0
Lot number
JP-24-25
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Female
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENTS' TOE WAS CAUGHT ON THE STITCHING BETWEEN MESH AND LEATHER. THE PATIENTS' BIG TOENAIL ON THE LEFT FOOT CAME OFF, BLOOD WAS PRESENT ON THE SHOE. THE SHOE WAS RETURNED AND EVALUATED. THE COMPLAINT HAS BEEN CONFIRMED; IT WAS FOUND THERE IS STITCHING HANGING DOWN IN THE TOE BOX AREA. 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 THAT THE PATIENTS' TOE WAS CAUGHT ON THE STITCHING BETWEEN MESH AND LEATHER. THE PATIENTS' BIG TOENAIL ON THE LEFT FOOT CAME OFF, BLOOD WAS PRESENT ON THE SHOE.