DR COMFORT
Received Oct 9, 2025 · Event occurred Sep 15, 2025
Report 3008579854-2025-00005 · MDR key 23262953
Device
Generic name
Ruk, Black, 10.5, Medium
Manufacturer
Dr Comfort; A Djo Llc CompanyCatalog number
7910-M-10.5
Lot number
ST-23-25
Product problems
- Sharp Edges
- Sharp Edges
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "LEFT SHOE HAS A STAPLE POKING IN TOE" THE PATIENT DID NOT WEAR THE SHOE. WHILE INSERTING THE ORTHOTIC INSERT INTO THE LEFT RUK SHOE, WE NOTICED A STAPLE PROTRUDING NEAR THE TOE AREA.
Additional Manufacturer Narrative
IT WAS REPORTED THAT "LEFT SHOE HAS A STAPLE POKING IN TOE AREA" THE PATIENT DID NOT WEAR THE SHOE. WHILE INSERTING THE ORTHOTIC INSERT INTO THE LEFT RUK SHOE, WE NOTICED A STAPLE PROTRUDING NEAR THE TOE AREA. EVALUATION OF SHOE FOUND A STAPLE INSIDE SHOE IN TOE BOX AREA. CONPLAINT HAS BEEN CONFIRMED. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.