DR COMFORT
Received Oct 30, 2024 · Event occurred Oct 2, 2024
Report 3008579854-2024-00006 · MDR key 20575005
Device
Generic name
Theresa, Black, 08.5, Medium
Manufacturer
Dr Comfort; A Djo, Llc CompanyCatalog number
11710-M-08.5
Lot number
FY-20-22
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Ulcer
- Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT DEVELOPED SORES ON THEIR TOES THAT REQUIRED MEDICAL TREATMENT FROM WEARING THE SHOES. THE PRODUCT WAS RETURNED FOR EVALUATION THE COMPLAINT COULD NOT BE CONFIMED AS REPORTED. THE ROOT CAUSE IS RELATED TO FIT ISSUE, NOT RELATED TO DEVICE OR MANUFACTURING DEFECT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE 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 DEVELOPED SORES ON THEIR TOES THAT REQUIRED MEDICAL TREATMENT FROM WEARING THE SHOES.