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Received Aug 31, 2011 · Event occurred Aug 25, 2011
Report 2250667 · MDR key 2250667
Device
Product problems
- Insufficient Device Problem Information
Patient
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- Erythema
Narrative
Description of Event or Problem
PT RECEIVING NEUROMUSCULAR RE-EDUCATION TO BILATERAL VASTUS MEDIALIS OBLIQUUS (VMO) BY WAY OF RUSSIAN E-STIM USING ELECTRODES. PT HAD SPOTS ON BILATERAL KNEES, TWO ON EACH KNEE THAT APPEARED TO BE MOLES. AFTER PT RECEIVED E-STIM, AREA TO PLACEMENT OF ELECTRODES WAS PINKISH IN COLOR, HOWEVER, NO SPOT NOTED. (NO VISIBLE SPOT OR BURN). PT THEN CAME IN ONE DAY LATER AND 5 DAYS LATER. ON THIS LATTER DATE, A SMALL SPOT APPROXIMATELY 2MM NOTED. NOT RAISED OR BLISTERED, JUST SPOT THAT APPEARS TO LOOK LIKE OTHER SPOTS ON LEG. LAST TREATMENT OF E-STIM WAS GIVEN 5 DAYS PREVIOUS TO IDENTIFICATION OF SPOT. CLINICAL ENGINEERING NOTIFIED TO CHECK EQUIPMENT.