BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTOPHORESIS

    MDR report key: 318815 · Received March 2, 2001

    Report

    Report Number
    318815
    Event Type
    Other
    Date Received
    March 2, 2001
    Date of Event
    January 31, 2001
    Report Date
    February 20, 2001
    Manufacturer
    IO MED
    Product Code
    EGJ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PT WAS RECEIVING IONTOPHORESIS THE UNIT SHUT DOWN AND GAVE THE PT A BRIEF SHOCK TO RIGHT LATEPICONDYLE. THE PT DID NOT OFFER ANY COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9055 IONTOPHORESIS * EGJ IO MED PHORESOR II AUTO NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other OF THE EVENT.| NOTHING ELSE WAS BEING USED ON PATIENT AT THE TIME