BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2250667 · Received August 31, 2011

    Report

    Report Number
    2250667
    Date Received
    August 31, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 31, 2011
    Manufacturer
    DJO LLC
    Product Code
    IPF
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STIMULATOR, MUSCLE, POWERED IPF DJO LLC 00261 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *