InjuryFYH
DELTA-SPLINT SYNTH RL 4" X 15FT
Received Oct 22, 2003
Report 1818910-2003-00709 · MDR key 490745
Device
Generic name
Soft Goods
Manufacturer
Depuy Ortho Tech- North Brunswick J&j Co.Model number
NACatalog number
51143
Lot number
3106
Product problems
- Device Emits Odor
- Device, removal of (non-implant)
Patient
NA
- Blister(s)
- Skin Irritation
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
AFTER 5 DAYS OF USE IT STARTED TO STINK. THE PT HAD MACERATIONS AND BLISTERS ON SKIN. WHEN THE SPLINT WAS REMOVED THERE WERE SPOTS ON THE SPLINT AND THE PT'S SIDE.
Remedial action
- Other