BEUDAMED
    FDA Adverse Event Summary report: N

    THERATOUCH 4.7

    MDR report key: 2431161 · Received January 18, 2012

    Report

    Report Number
    2431161
    Date Received
    January 18, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 18, 2012
    Manufacturer
    RICH-MAR, INC.
    Product Code
    GZJ
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE E-STIM DEVICE CAUSED BURN BLISTERS TO A PATIENT. THIS IS THE SECOND OF SUCH OCCURRENCE WITH THIS PARTICULAR DEVICE. INITIAL INCIDENT WAS REPORTED TO MEDSUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERATOUCH 4.7 MUSCLE STIMULATOR, ELECTRICAL/ULTRASOUND, THERAPEUTIC GZJ RICH-MAR, INC. THERATOUCH 4.7 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR