PROHEELX HEEL PROTECTOR
Received May 2, 2012
Report 2020362-2012-00326 · MDR key 2571772
Device
Product problems
- Insufficient Device Problem Information
Patient
83 YR
- Pressure Sore/Ulcer
Narrative
Description of Event or Problem
CUSTOMER REPORTED A PT THAT USED A PRO-HEELX PRODUCT ON THE BED AND USED A LOUNGE CHAIR HAD DEVELOPED A HEEL BLISTER. ADD'L INFO PROVIDED BY THE USER FACILITY STATED: THE PT SUFFERED FROM STAGED DEMENTIA AND POOR NUTRITION. THE PT WAS A HIGH RISK PT; HER MOVEMENT IS LIMITED AND USED A LOUNGE CHAIR. NURSING STAFF WAS NOTIFIED WHEN THE PT HAD FULLY DEVELOPED A BLISTER WITH FLUID ON HER LEFT FOOT. THE BLISTER WAS NOT LOCATED DIRECTLY ON THE HEEL, BUT TOWARD THE SIDE OF THE HEEL THROUGH THE BACK AND NOT IN THE CENTER. THE PT'S FEET WERE PROTECTED AND PT'S MOVEMENT WAS ALTERNATED. THE PT WAS TREATED WITH ANTIBIOTIC DRESSING AND THE BLISTER IMPROVED. THE PT IS DOING WELL. THERE WAS NO SURGICAL INTERVENTION REPORTED.
Additional Manufacturer Narrative
FACILITY STATED: THAT THE PRODUCT REMAINS IN USE AND WILL NOT BE RETURNED. (B)(4).