#1 SUPER SPLINT
Received Jun 10, 2002 · Event occurred Apr 22, 2002
Report 2921578-2002-00002 · MDR key 399179
Device
Product problems
- Use of Device Problem
Patient
*
- Burn(s)
- Discomfort
- Surgical procedure
Narrative
Description of Event or Problem
PT REQUIRED SPLINTING FOR TRACTION OF LEFT ANKLE FRACTURE, AFTER SPLINTING MATERIAL WAS APPLIED AND CASTED LEG WAS SURROUNDED BY PILLOW FOR POSITIONING. PT COMPLAINED OF EXTREME HEAT. SECOND DEGREE BURNS NOTED BY FACILITY AFTER PT WAS TRANSFERRED TO O.R. FOR SURGERY. CONTACT WITH THE HOSPITAL ALLOWED FOR DETERMINATION THAT DURING PLACEMENT OF SPLINT, THE PT COMPLAINED OF EXCESSIVE HEAT. HEALTHCARE WORKERS DISREGARDED SPECIFIC INSTRUCTIONS FOR USE ON DEVICE AND COMPLAINTS FROM PT AND KEPT DEVICE ON PT. BURNS DISCOVERED BY SURGEON AFTER PT WAS TRANSFERRED TO HOSPITAL. PRODUCT WAS FOUND TO HAVE PERFORMED TO MANUFACTURING SPECIFICIATIONS AS EXPECTED.