BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT 1.5

    MDR report key: 2367709 · Received April 26, 2011

    Report

    Report Number
    1721293-2011-00003
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 22, 2011
    Manufacturer
    EMPI, INC.
    Product Code
    GZJ
    PMA / PMN Number
    K061650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SELECT 1.5 DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION AND MET ALL ELECTRICAL SPECS. IN ADDITION TO THE DEVICE, THE FOLLOWING ACCESSORIES WERE RETURNED: LEADWIRE, 193068-100, LOT #010010326, (TWO USED LEADWIRES RETURNED). ELECTRODES, 198622-001, LOT # 006041, USE BY DATE: 2012-03, (ONE OPENED PACKAGE WITH EIGHT USED ELECTRODES RETURNED) BATTERIES, (B)(4), AA, ALKALINE BATTERIES, LOT # 1053099. ALL ACCESSORIES WERE EVALUATED AND MET PHYSICAL AND ELECTRICAL SPECS. FOUR OF THE USED ELECTRODES WERE DEHYDRATED, BUT STILL MET ELECTRICAL SPECS. PER THE LABELING: SKIN IRRITATION, INFLAMMATION, AND ELECTRODE BURNS BENEATH THE ELECTRODES ARE POTENTIAL ADVERSE REACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO EMPI THAT A PT RECEIVED A 2ND DEGREE BURN AS A RESULT OF USING THE SELECT 1.5 DEVICE AND ELECTRODES. THE PT WAS USING THE SMP (PROGRAM FOR BACK) MODE, INTENSITY USED WAS 6.5 AND SHE USED BOTH CHANNELS (4 ELECTRODES). THE ELECTRODES WERE PLACED ABOUT 3-4 INCHES APART AT THE TOP OF HER NECK IN THE HAIR LINE AND DOWN TO THE RIGHT SHOULDER. THIS TREATMENT WAS THE FIRST THE PT HAD USED THE TENS AT HOME, AND SHE HAD EXPERIENCED NO PREVIOUS ADVERSE RESPONSE WITH TENS TREATMENTS IN THE CLINIC. ON (B)(6) 2011, PT RETURNED TO THE CLINIC WITH BLISTERS ON THE BACK OF HER NECK AND HAIR LINE. THE PT REPORTED NO DISCOMFORT OR ADVERSE FEELING DURING THE COURSE OF THE TENS. THE PT NOTICED SMALL RAISED RED BLISTERS AT THE BASE OF HER NECK FROM UNDER THE ELECTRODES; THEY WERE PAINFUL AND ITCHY. THE NEXT MORNING THE PT HAD SIGNIFICANT PAIN AND WAS UNABLE TO LIFT HER RIGHT ARM. ON (B)(6) 2011, PT WENT TO ER FOR INFECTION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2011, PT WENT TO HER PRIMARY CARE PHYSICIAN AND CONFIRMED ER DIAGNOSIS. ON (B)(6) 2011, PT WENT TO A DERMATOLOGIST WHO CULTURED THE RASH, NO IMPROVEMENT WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT 1.5 SELECT 1.5, PRODUCT: GZJ GZJ EMPI, INC. 199584-001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR