PROTECTOR,HEEL,HEELMEDIX W/WEDGE,4/CS
Received Aug 22, 2021 · Event occurred Aug 1, 2021
Report 1417592-2021-00160 · MDR key 12352104
Device
Generic name
Protector,heel,heelmedix W/wedge,4/cs
Manufacturer
Medline Industries Inc.Catalog number
MDT823330SWCS
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A PATIENT EXPERIENCED A PRESSURE ULCER DURING USE OF THE PRODUCT. REPORTEDLY, THE HEEL PROTECTOR WAS USED IN CONJUNCTION WITH AN SEQUENTIAL COMPRESSION DEVICE (SCD) SLEEVE. THE PRESSURE ULCER WAS NOTED BY THE REPORTING FACILITY'S WOCN NURSE WHO INDICATED THAT IT "WAS NOT A SIZING ISSUE, IT WAS TUBING FROM THE SCD." NO INFORMATION WAS PROVIDED AS TO WHAT STAGE THE PRESSURE ULCER WAS AT THE TIME THAT IT WAS NOTED AND NO INFORMATION RELATED TO MEDICAL TREATMENT WAS PROVIDED TO THE MANUFACTURER. NO SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION AND A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED DEVELOPMENT OF A PRESSURE ULCER, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A PRESSURE ULCER DURING USE OF THE PRODUCT.