BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUPEL

    MDR report key: 391194 · Received April 29, 2002

    Report

    Report Number
    2182686-2002-00007
    Event Type
    Other
    Date Received
    April 29, 2002
    Date of Event
    February 22, 2002
    Report Date
    March 15, 2002
    Manufacturer
    EMPI
    Product Code
    EGJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING IONTOPHORESIS TREATMENT, A PATIENT RECEIVED A BURN. THE DEVICE, DUPEL, WAS USED WITH DUPEL ELECTRODES. THE PATIENT WAS TREATED BY A PHYSICIAN WHO APPLIED NEOSPORIN ON THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUPEL IONTOPHORESIS DUAL CHANNEL EGJ EMPI NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other