PRIMO
Received Dec 20, 2025 · Event occurred Jul 29, 2024
Report 3004824601-2025-00222 · MDR key 23858554
Device
Generic name
Heel Offloading Boot
Model number
HC1WProduct problems
- Inadequate or Insufficient Training
- Inadequate or Insufficient Training
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. THE EVENT WAS EVALUATED AND DETERMINED NOT TO INVOLVE A DEVICE MALFUNCTION OR SERIOUS INJURY; THE ROOT CAUSE WAS IDENTIFIED AS A USE ERROR. HOWEVER, GIVEN THAT A MINOR INJURY WAS REPORTED, THE EVENT IS BEING REPORTED IN LINE WITH APPLICABLE VIGILANCE REPORTING REQUIREMENTS.
Description of Event or Problem
ON (B)(6) 2024, CUSTOMER REPORTED THAT HC1W HEELCHECK BOOT, STANDARD W/WEDGE CAUSED A HEEL PRESSURE INJURY ABOVE THE HEEL ON A PATIENT.