MalfunctionNOC
EXOS SPLINT
Received Feb 7, 2019 · Event occurred Dec 26, 2018
Report MW5083846 · MDR key 8320671
Device
Generic name
Splint, Extremity, Non-inflatable, External, Non-sterile
Manufacturer
Djo, LlcProduct problems
- Product Quality Problem
Patient
50 YR
- Erythema
- Pain
- Erythema
- Pain
Narrative
Description of Event or Problem
THE PT WAS PLACED IN A SPLINT IN THE ORTHOPEDIC OFFICE. SHE WENT TO THE ED COMPLAINING THAT THE SPLINT WAS CAUSING PAIN AND A REDDENED AREA. THE ED PLACED A NEW SPLINT. IT WAS DISCOVERED THAT THE FOAM INSIDE OF THE SPLINT HAD BEEN CUT TOO SHORT, EXPOSING THE HARD AREA OF THE SPLINT ON A PORTION OF THE SPLINT.