inforMED

*

Received Aug 31, 2011 · Event occurred Aug 25, 2011

Report 2250667 · MDR key 2250667

Device

Generic name

Stimulator, Muscle, Powered

Manufacturer

Djo Llc

Model number

00261

Catalog number

*

Lot number

*

Product problems

  • Insufficient Device Problem Information

Patient

*

  • 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.