BEUDAMED
    FDA Adverse Event Summary report: N

    CHATANOOGA

    MDR report key: 3874448 · Received May 16, 2012

    Report

    Report Number
    3874448
    Date Received
    May 16, 2012
    Date of Event
    January 16, 2014
    Report Date
    May 9, 2014
    Product Code
    IMG
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A PT WHO WAS UNDERGOING A PHYSICAL THERAPY TREATMENT WITH A CHATTANOOGA TENS UNIT. HE SUSTAINED A POSSIBLE 3RD DEGREE BURN ABOUT 10 X 6 MM ON THE RIGHT LOWER LUMBAR AREA, WITH DARK GRAYISH DISCOLORATION AND A GROUP OF BLISTERS REPRESENT 2ND DEGREE BURN AROUND THE AREA. THE UNIT WAS TURNED UP TO THE PT'S TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHATANOOGA TENS UNIT IMG VECTRA GENISYS 2761

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other