InjuryLPQ
EXOGEN 4000+
Received Nov 4, 2011 · Event occurred Oct 16, 2011
Report 1020279-2011-00459 · MDR key 2324634
Device
Generic name
Exogen 4000+
Manufacturer
Smith & Nephew OrthopaedicsCatalog number
71034100
Lot number
1210065258E
Product problems
- Insufficient Device Problem Information
Patient
14 YR
- Skin Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED MILD TO MODERATE SKIN IRRITATION WHILE USING THE DEVICE.
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED A REVISION SURGERY WAS PERFORMED INVOLVING A SMITH AND NEPHEW PRODUCT, IT IS CONCLUDED THAT IN ACCORDANCE WITH THE REGULATIONS SET FORTH UNDER 21 CFR 803, IT IS CONCLUDED THAT THIS IS A REPORTABLE EVENT.