BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2503845 · Received March 19, 2012

    Report

    Report Number
    1723686-2012-00002
    Event Type
    Other
    Date Received
    March 19, 2012
    Date of Event
    December 29, 2011
    Report Date
    March 19, 2012
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT SHE RECEIVED MULTIPLE BLISTERS ON HER SKIN WHERE THE ELECTRODES WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX TENS ELECTRICAL STIMULATOR IPF ZYNEX MEDICAL, INC. TRUWAVE PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other