ACTION PATCH ELECTRODE
Received Sep 17, 2010 · Event occurred Aug 12, 2010
Report 1721293-2010-00016 · MDR key 1841536
Device
Product problems
- Device Operates Differently Than Expected
Patient
13 YR
- Burning Sensation
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT WAS BURNED USING THE ACTION PATCH. PT WAS BEING TREATED FOR PATELLAR TENDINITIS, THIS WAS THE THIRD TREATMENT. THE COMPOUND USED WAS DEXAMETHASONE, 2.0 CC AT A CONCENTRATION OF 4 MG/DL. THE PT DID NOTICE A BURNING SENSATION AND LEFT THE PATCH ON FOR 2 HOURS. THE BURN WAS NOTICED WHEN THE PATCH WAS REMOVED. NO MEDICAL INTERVENTION WAS NEEDED.
Additional Manufacturer Narrative
THE ACTION PATCH WAS NOT ABLE TO BE TESTED ELECTRICALLY AS IT WAS USED. THE ACTION PATCH WAS RETURNED WITH NO KARAYA GEL ON THE PATCH. USING THE PATCH WITHOUT KARAYA COULD HAVE CONTRIBUTED TO THE PT BURN: A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.