InjuryLPQ
EXOGEN
Received May 6, 2011 · Event occurred Apr 20, 2011
Report 1020279-2011-00150 · MDR key 2080424
Device
Generic name
Bone Growth Stimulator
Manufacturer
Smith & Nephew, OrthopedicsModel number
EXOGEN 4000+ SYSTEMCatalog number
71034100
Lot number
0910051106E
Product problems
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT DEVELOPED A MILD SKIN IRRITATION WHILE USING THE EXOGEN DEVICE. IT WAS NOTED BY THE TREATING THE PATIENT DID FOLLOW USAGE INSTRUCTIONS. THE DEVICE WAS NOT FAULTED.