HEELMEDIX

Description of Event or Problem

WHILE WEARING THE DEVICE, THE PATIENT DEVELOPED A PRESSURE ULCER ON THE CALF OF HIS RIGHT LEG.

Additional Manufacturer Narrative

THE FACILITY REPORTED THAT AFTER WEARING THE HEEL PROTECTORS FOR TWO DAYS, THE BOOTS WERE REMOVED AND A PRESSURE ULCER WAS NOTED ON HIS RIGHT CALF. THIS PATIENT HAD MANY CO-MORBIDITIES AND HAD BEEN HOSPITALIZED FOR OVER A YEAR WITH MULTIPLE COMPLICATIONS. THE CONTACT AT THE FACILITY INDICATED THAT SKIN ASSESSMENTS WERE DONE ROUTINELY, HOWEVER THE PRESSURE ULCER BECAME UNSTAGEABLE. IT IS UNK IF THE DEVICE WAS APPROPRIATELY SIZED OR APPLIED CORRECTLY. THE FACILITY REPORTED THE PRESSURE ULCER WAS PRIMARILY RELATED TO THE PATIENT'S CONDITION AND CO-MORBIDITIES. THEY HAD NO INFORMATION TO SUGGEST THE DEVICE CAUSED THE TISSUE INJURY BUT REPORTED IT IN AN ABUNDANCE OF CAUTION. NO SAMPLE WAS RETURNED FOR EVALUATION. NO LOT NUMBER WAS PROVIDED.