MalfunctionFMP
ADVANCE SMARTGUARD GEL HEEL CUP
Received Jun 9, 2025 · Event occurred May 13, 2025
Report 22166115 · MDR key 22166115
Device
Generic name
Protector, Skin Pressure
Manufacturer
Advance Medical Designs, IncModel number
GEL-HCCatalog number
GEL-HC
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
12 YR · Male
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
PT SUSTAINED PRESSURE INJURIES DURING PROLONGED OR PROCEDURE (OPEN HEART SURGERY > 12 HOURS) DESPITE PROPER POSITIONING WITH GEL HEEL DEVICE.