DR COMFORT
Received Sep 10, 2024 · Event occurred Aug 13, 2024
Report 3008579854-2024-00003 · MDR key 20186466
Device
Generic name
Paradise Black 10 1/2 Medium
Manufacturer
Dr Comfort; A Djo, Llc CompanyCatalog number
2110-M-10.5
Lot number
VN394917
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE IS A STAPLE STICKING THE 5TH TOE.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THERE IS A STAPLE STICKING THE 5TH TOE. THE SHOE WAS RETURNED TO ENOVIS FOR EVALUATION. THE PRODUCT WAS INSPECTED, DEFECT CONFIRMED DUE TO STAPLE FOUND STICKING OUT NEAR TOE BOX OF RIGHT SHOE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION TO VERIFY IF THERE WAS AN INJURY THAT OCCURRED DUE TO THE REPORTED ISSUE WITHOUT A RESPONSE. ROOT CAUSE MAY BE ATTRIBUTED TO A MANUFACTURING DEFECT. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.