HEELMEDIX
Received Feb 25, 2015 · Event occurred Oct 29, 2014
Report 4584932 · MDR key 4584932
Device
Generic name
Protector, Skin Pressure
Manufacturer
Medline Industries, Inc.Model number
MDT823330CSCatalog number
MDT823330CS
Lot number
*
Product problems
- Insufficient Device Problem Information
Patient
41 YR
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
WE WERE TRIALING THESE NEW OFF-LOADING DEVICES FOR AN ALTERNATIVE TO MULTI-PURPOSE FOOT BOOTS WHO JUST NEED OFFLOADING OF HEELS. I AM NOT SURE THE DAY THEY REPLACED THE BOOTS, BUT THE STAFF NOTES AREAS OF IRRITATION ON THE HEEL AND CONTACTED THE COMPANY REPRESENTATIVE. THE HEELMEDIX DEVICES WERE REMOVED AT THAT POINT BUT THE PATIENT DEVELOPED PRESSURE ULCERS ON HIS RIGHT CALF THAT BECAME UN-STAGEABLE PRESSURE ULCERS. WE REPORTED THIS AS A SENTINEL EVENT AND PERFORMED A ROOT CAUSE ANALYSIS. THESE HEELMEDIX DEVICES HAVE BEEN IMPLEMENTED IN OUR FACILITY. WE FEEL THAT THESE ULCERS WERE PRIMARILY RELATED TO THE PATIENT'S CONDITION BUT FELT IT SHOULD BE REPORTED IN CASE THIS IS A COMMON TREND, SUCH AS OBESE OR DIABETIC PATIENTS, IN WHICH CASE AN ALTERNATIVE METHOD SHOULD BE USED FOR OFF-LOADING.