PRIMO
Received Dec 18, 2025 · Event occurred Jul 7, 2023
Report 3004824601-2025-00211 · MDR key 23837240
Device
Generic name
Heel Offloading Boot
Model number
BAB11000Product 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; 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) 2023, CUSTOMER REPORTED THAT PATIENTS WERE EXPERIENCING HEEL INJURIES WHILE USING BAB11000 PRIMO BOOT, PURPLE/NAVY - STANDARD.