DR COMFORT
Received Sep 10, 2024 · Event occurred Aug 13, 2024
Report 3008579854-2024-00002 · MDR key 20186455
Device
Generic name
Patrick Multi 10 Wide
Manufacturer
Dr Comfort; A Djo, Llc CompanyCatalog number
8560-W-10.0
Lot number
UNKNOWN
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 · Unknown
- Unspecified Infection
- Ulcer
- Unspecified Infection
- Ulcer
Narrative
Description of Event or Problem
PATIENT ALLEGES DR. COMFORT SHOE CAUSED AN ULCER WHICH TURNED INTO AN INFECTION RESULTING IN TWO PARTIAL AMPUTATIONS.THE FOOT DEVELOPED ULCERS WHICH TURNED INTO AN INFECTION FROM WEARING THE DEFECTIVE SHOE. AFTER TWO PARTIAL AMPUTATIONS, APPROXIMATELY 50% OF FOOT REMAINS RESULTING IN SEVERE MOBILITY ISSUES. THE DATE OF INJURY WAS (B)(6) 2021 AS A RESULT OF THE INSIDE THE SHOE COMING UNDONE AND CREATING THE ULCER AND SUBSEQUENT SEVERE INFECTIONS.
Additional Manufacturer Narrative
PATIENT ALLEGES DR. COMFORT SHOE CAUSED AN ULCER WHICH TURNED INTO AN INFECTION RESULTING IN TWO PARTIAL AMPUTATIONS.THE FOOT DEVELOPED ULCERS WHICH TURNED INTO AN INFECTION FROM WEARING THE DEFECTIVE SHOE. AFTER TWO PARTIAL AMPUTATIONS, APPROXIMATELY 50% OF FOOT REMAINS RESULTING IN SEVERE MOBILITY ISSUES. THE DATE OF INJURY WAS (B)(6) 2021 AS A RESULT OF THE INSIDE THE SHOE COMING UNDONE AND CREATING THE ULCER AND SUBSEQUENT SEVERE INFECTIONS. THE SHOE HAS NOT BEEN RETURNED FOR EVALUATION THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.