inforMED
InjuryFMP

HEELMEDIX

Received Feb 25, 2015 · Event occurred Oct 29, 2014

Report 4584932 · MDR key 4584932

Device

Generic name

Protector, Skin Pressure

Model number

MDT823330CS

Catalog 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.