MalfunctionEGJ
ACTION PATCH ELECTRODE
Received Jan 8, 2010 · Event occurred Nov 24, 2009
Report 1721293-2009-00026 · MDR key 1589421
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burning Sensation
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI, THAT A PATIENT RECEIVED A 2CM BURN FROM THE DISPERSE SIDE OF AN ACTION PATCH WHILE TREATING SCAR TISSUE FROM A (B)(6) ARTHROSCOPIC SURGERY OF THE RIGHT KNEE. THIS WAS A 6 HOUR TREATMENT AND PATIENT NOTICED BURNING SENSATION WITH IN 3 HOURS AND REMOVED THE PATCH. PATIENT WAS GIVEN ANTIBIOTICS.
Additional Manufacturer Narrative
METHOD AND RESULTS: WE ARE UNABLE TO EVALUATE AS NO PRODUCT WAS RETURNED; THE PATIENT DISPOSED OFF THE ELECTRODE. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.