MalfunctionFMP
FOAM PADDING 4.5" X 24"
Received Jan 28, 2021 · Event occurred Dec 7, 2020
Report 11243137 · MDR key 11243137
Device
Generic name
Protector, Skin Pressure
Manufacturer
BiosealProduct problems
- Product Quality Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
CHILDREN WITH CEREBRAL PALSY AND AN A-FRAME CAST ARE AT RISK FOR FOAM PADDING TO BREAK DOWN, WHICH INCREASES RISK FOR PRESSURE INJURIES.