MalfunctionFMP
HEEL MEDIX BASIC HEEL PROTECTOR
Received Apr 29, 2020 · Event occurred Apr 13, 2020
Report MW5094321 · MDR key 10013234
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
82 YR
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
OBSERVED THAT PATIENT WAS DEVELOPING A PRESSURE INJURY TO THE RIGHT LATERAL AND MEDIAL ASPECT OF FOOT SECONDARY TO NEW OFF LOADING BOOTS, MEDLINE HEEL MEDIX. IT IS OFF LOADING HOWEVER, FOR PEOPLE WITH FRAGILE SKIN IT CAUSES PRESSURE INJURY. THE WOUND CARE NURSE HAS SEEN THIS OCCUR IN OTHER PATIENTS AT OTHER HOSPITALS. THERAPY DATES: (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).