InjuryFSZ
MAST QUADRANT RETRACTOR SYSTEM
Received Sep 10, 2009 · Event occurred Jul 17, 2009
Report 1030489-2009-00833 · MDR key 1469154
Device
Generic name
Illumination
Manufacturer
Medtronic Sofamor DanekModel number
NACatalog number
9560658
Lot number
UNK
Product problems
- Component(s), overheating of
Patient
Not reported
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LIGHT SOURCE CORD BURNED THE PT AT LOWER BACK DURING USE AND CAUSED A TWO INCHES DIAMETER SECOND DEGREE BURN TO THE PT. NO OTHER PT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.