MalfunctionITS
MAPLE LEAF
Received Oct 19, 2018 · Event occurred Oct 3, 2018
Report 7983914 · MDR key 7983914
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
PRESSURE ULCER DEVELOPED ON THE POSTERIOR RIGHT LEG LOCATED UNDER THE BRACE. BACK OF THE BRACE WAS NOTED TO BE HARD AND APPLIED PRESSURE TO THE THIGH.