PROHEELX HEEL PROTECTOR
Received May 2, 2012
Report 2020362-2012-00325 · MDR key 2570784
Device
Product problems
- Insufficient Device Problem Information
Patient
96 YR
- Death
- Tissue Damage
Narrative
Description of Event or Problem
CUSTOMER REPORTED A PT THAT USED THE PRO-HEELX PRODUCT ON THE BED AND USED A LOUNGE CHAIR AND DEVELOPED HEEL BLISTERS. ADDITIONAL INFO PROVIDED BY THE USER FACILITY STATED: THE PT SUFFERED FROM STAGED DEMENTIA, POOR NUTRITION, AND EDEMA. THE PT WAS A HIGH RISK PT; HER MOVEMENT WAS LIMITED AND USED A LOUNGE CHAIR. NURSING STAFF WAS NOTIFIED WHEN THE PT HAD FULLY DEVELOPED A BLISTER WITH FLUID ON EACH FOOT. THE BLISTERS WERE 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 THE PT'S MOVEMENT WAS ALTERNATED. THE PT WAS TREATED WITH ANTIBIOTIC DRESSING AND THE BLISTERS IMPROVED. THERE WAS NO SURGICAL INTERVENTION. THE PT HAS SINCE EXPIRED; THE CAUSE WAS DETERMINED AS RESPIRATORY AND CARDIO.
Additional Manufacturer Narrative
FACILITY STATED: THAT THE PRODUCT REMAINS IN USE AND WILL NOT BE RETURNED. (B)(4).