BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPI SELECT TRANSCUTANEOUS ELECTRIC NERVE STI

    MDR report key: 1338111 · Received March 4, 2009

    Report

    Report Number
    2182686-2009-00002
    Event Type
    Injury
    Date Received
    March 4, 2009
    Date of Event
    January 1, 2009
    Report Date
    March 4, 2009
    Manufacturer
    EMPI
    Product Code
    GZJ
    PMA / PMN Number
    K072946
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO EVALUATE DEVICE BECAUSE PATIENT CONTINUES TO USE THE DEVICE ON OTHER AREAS OF THE BODY WITH NO PROBLEM AND WILL NOT RETURN DEVICE. THEREFORE, EMPI DOES NOT BELIEVE THERE WAS A DEVICE MALFUNCTION. TRIED CONTACTING PATIENT BY PHONE SEVERAL TIMES TO FOLLOW UP WITH PATIENT, HOWEVER, EMPI IS UNABLE TO MAKE CONTACT WITH THE PATIENT. A SUPPLEMENTAL REPORT MAY BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT NOTICED THAT THE DEVICE DIDN'T HAVE A SETTING FOR HIS ANKLE, BUT TRIED THE PRODUCT ON HIS ANKLE ANYWAYS. HE SAID HE HAD ELECTRODE 5 TO 6 INCHES ABOVE HIS ANKLE BONE (ONE ELECTRODE ON THE INSIDE OF HIS LEG, THE OTHER ON THE OUTSIDE OF HIS LEG). HE SAID HE RECEIVED A BURN ON HIS ANKLE. HE SAID FOR THE NEXT 3 TO 4 DAYS HIS LEG WAS SWELLING UP, GOT INFECTED, AND HAD TO GO TO THE ER ON DECEMBER 6TH, WHERE THE ER DOCTOR GAVE HIM AN ANTIBIOTIC AND TOLD HIM IT WAS CELLULITIS. HE SAID HE HAS SINCE USED THE SAME ELECTRODES, ON HIS SHOULDER, AND THE ELECTRODES STILL SEEM TO WORK AND HAS NOT RECEIVED ANY BURNS OR ISSUES ON HIS SKIN, JUST ON HIS ANKLE ONLY. HE SAID HE WANTS TO HOLD ONTO THE DEVICE AND WILL NOT RETURN THE DEVICE. HE SAID HE HAS TO STILL MAKE A FOLLOW-UP WITH HIS PHYSICIAN, BUT HASN'T DONE SO YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPI SELECT TRANSCUTANEOUS ELECTRIC NERVE STI TENS GZJ EMPI 199532-001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention