MÖLNLYCKE Z-FLEX HEEL BOOT

Description of Event or Problem

A PATIENT EXPERIENCED A PRESSURE INJURY ON THE DISTAL ACHILLES THAT THE FACILITY ATTRIBUTED TO THE HEEL BOOT NO LONGER PROVIDING PROTECTION DUE TO RIDING UP THE LEG COMBINED WITH INSUFFICIENT AIR. EDUCATION ON THE INTENDED USE OF THE PRODUCT, A REVIEW OF THE INSTRUCTIONS FOR USE, INCLUDING RECOMMENDATIONS FOR USE IN CONJUNCTION WITH A SEQUENTIAL COMPRESSION DEVICE (SCD) UNDERNEATH THE HEEL BOOT WERE PROVIDED TO THE FACILITY AND THE "SISTER" FACILITY. MULTIPLE REQUESTS WERE MADE FOR ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS OBTAINED ON 15AUG2019. A HOSPITAL ACQUIRED PRESSURE INJURY LOCATED ON THE ACHILLES TENDON AREA WAS FIRST DOCUMENTED ON (B)(6) 2017 OF A PATIENT THAT HAD BEEN HOSPITALIZED SINCE (B)(6) 2019. USE OF THE BOOT WAS DISCONTINUED ON (B)(6) 2019. THE EVENT PROGRESSED TO AN UNSTAGEABLE ULCER, BUT THE TIMELINE WAS NOT PROVIDED. UNSPECIFIED TREATMENT WAS REQUIRED. A SEQUENTIAL COMPRESSION DEVICE (SCD) WAS BEING USED UNDERNEATH THE HEEL BOOT. PHOTOS OF THE INJURY WERE OBSERVED TO SHOW STRIATIONS ACROSS THE ACHILLES TENDON INCONSISTENT WITH THE HEEL BOOT DESIGN. IT IS UNKNOWN HOW CONSISTENTLY THE HEEL BOOT WAS BEING USED OR IF IT WAS BEING USED CORRECTLY. THE FACILITY REPORTS NO FURTHER INJURIES HAVE BEEN IDENTIFIED ON PATIENTS USING THE HEEL BOOT. NO ADDITIONAL INFORMATION IS AVAILABLE OR EXPECTED.